FORM MD-5

[See sub-rule (4) of rule 20 and sub-rule (6) of rule 20]

Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device

Licence Number: MFG/MD/2023/000843

1. M/s MADHU INSTRUMENTS PVT. LTD., F-90/3D, OKHLA INDUSTRIAL AREA, PHASE-1OKHLA, South Delhi,
Delhi (India) - 110020 Telephone No.: 01142701031 FAX: 01142701030 has been licenced to manufacture for sale or
for distribution the below listed medical device(s) at the premises situated at M/s Madhu Instruments Pvt. Ltd., A-260,
Okhla Industrial Area, Phase-I, New Delhi, South Delhi, Delhi (India) - 110020 Telephone No.: 01142701030 FAX:
01142701031
2. Details of medical device(s) [Annexed]

3. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.

ANNEXURE
S.No. Details Of Device(s)
Generic Name:Schirmer Tear Test Strips
1 Model No.:Schirmer Tear Test Strips without Blue Mark - In House ,Schirmer Tear
Test Strips with Blue Mark - In House
Intended Use:A disposable sterile Schirmer Tear Test Strip (external use only) is
used to measure the amount of tear secretion of the eye
Class of medical device:Class A
Material of construction:Whatman Filter Paper no. 41
Dimension(if any):41 graduated strip (5mm width x 41mm length) with a least
count of 1 mm
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Tear Touch
Generic Name:Rose Bengal Strips
2 Model No.:NIL
Intended Use:A disposable sterile Rose Bengal Strip is used as a vital stain which
stains devitalized or degenerated epithelial cells as well as mucous filaments
Class of medical device:Class A
Material of construction:Whatman Filter Paper no. 1
Dimension(if any):7mm width x 60mm length
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Rose Touch
Generic Name:Lissamine Green Strips
3 Model No.:NIL
Intended Use:A disposable sterile ophthalmic diagnostic strip used when
superficial conjuctival or corneal tissue change is suspected.
Class of medical device:Class A
Material of construction:Whatman Filter Paper no. 1
Dimension(if any):7mm width x 60mm length
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Green Touch

Page 1 of 11
 Generic Name:Backflush Handle (Active Aspiration)
4 Model No.:NIL
Intended Use:Backflush Handle (Active Aspiration) is used for atraumatic removal
of intraocular fluids by active aspiration during vitreo-retina ophthalmic surgical
procedures. Safety feature of a backflush reservoir can be used to reflux back the
unwanted tissue or fluid aspirated during the procedure. This device is used with
desired ophthalmic cannula to complete the intended use.
Class of medical device:Class A
Material of construction:Nylon, Silicone, Polypropylene
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Intraocular Magnet
5 Model No.:NIL
Intended Use:This is an ophthalmic device used for atraumatic removal of
magnetic foreign bodies.
Class of medical device:Class A
Material of construction:Stainless Steel 304, Titanium
Dimension(if any):16G, 18G, 20G, 23G
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Diagnostic Lenses
6 Model No.:Single Mirror Gonio Lens - In House ,Two Mirror Gonio Lens - In House ,
Three Mirror Gonio Lens - In House ,Four Mirror Gonio Lens - In House
Intended Use:Gonio Lenses are used for viewing the anterior chamber angle and
retina and for static and dynamic gonioscopy
Class of medical device:Class A
Material of construction:Black Anodised Aluminium, Glass
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Opticlear
Generic Name:Laser Lenses
7 Model No.:YAG Capsulotomy Lens - In House ,YAG Iridectomy Lens - In house
Intended Use:These Lenses are used for YAG Laser Capsulotomy and YAG Laser
Iridectomy procedures.
Class of medical device:Class A
Material of construction:Black Anodised Aluminium, Glass
Dimension(if any):Standard Size
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Opticlear
Generic Name:Surgical Lenses
8 Model No.:Vitrectomy Lens Set - In House ,Irrigating Vitrectomy Lens Set - In House
Intended Use:These Lenses are used to visualize different area of the posterior
segment during a vitreo-retinal surgical procedure using a microscope
Class of medical device:Class A
Material of construction:Stainless Steel, Silicone, Glass
Dimension(if any):Standard Size
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Opticlear
Generic Name:Eyeball Stand
9 Model No.:Eyeball Stand - In House ,Eyeball Stand with Fixation Head - In House ,
Eye ball Stand (Slit Lamp Mounted) - In House
Intended Use:An Eyeball stand is used for micro-surgical training on Human /
Animal eyes and/or cutting a full/partial thickness donor button from intact globe.
Class of medical device:Class A
Material of construction:Stainless Steel, Aluminium, ABS
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL

Page 2 of 11
 Generic Name:Phaco Practice Eye
10 Model No.:NIL
Intended Use:A Phaco Practice Eye is a simulator eye for practicing the basic steps
of phaco surgery and getting good hand foot coordination on the phaco machines.
Class of medical device:Class A
Material of construction:Silicone, ABS
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Laser Practice Eye
11 Model No.:NIL
Intended Use:Laser Practice Eye is an ophthalmic teaching device used for
simulating green/red laser shots in an artificial diseased retina.
Class of medical device:Class A
Material of construction:Aluminium, Glass, Stainless Steel
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:MODEL EYE FOR INDIRECT OPHTHALMOSCOPY & RETINOSCOPY
12 Model No.:NIL
Intended Use:Model Eye for Indirect Ophthalmoscopy & Retinoscopy is an
ophthalmic teaching device used for practicing indirect ophthalmoscopy and
retinoscopy.
Class of medical device:Class A
Material of construction:Aluminium, Glass, Brass
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:CAM VISION STIMULATOR
13 Model No.:NIL
Intended Use:CAM Vision Stimulator is an ophthalmic device used to stimulate the
eye for treatment of Lazy / Amblyopic eye
Class of medical device:Class A
Material of construction:Aluminium, Plastic
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:PHACO PRACTICE EYE FIXATION HEAD
14 Model No.:NIL
Intended Use:Phaco Practice Eye Fixation Head is an artificial head used for
fixation of the phaco practice eyes and give a more natural feel of the human face
to the user.
Class of medical device:Class A
Material of construction:PVC, ABS, Stainless Steel, Aluminium, Silicone,
Polycarbonate
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Endothelial Punch
15 Model No.:NIL
Intended Use:This mechanical device gives an excellent donor corneal button
punched out from the endothelial side of corneoscleral button.
Class of medical device:Class A
Material of construction:Stainless Steel
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL

Page 3 of 11
 Generic Name:Irrigation and Aspiration Handpiece for Phaco
16 Model No.:NIL
Intended Use:This is an ophthalmic device used to safely aspirate the cortex
material during a cataract surgery.
Class of medical device:Class A
Material of construction:Titanium, Silicone
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Peroperative Keratoscope
17 Model No.:NIL
Intended Use:This is an ophthalmic device used during an ophthalmic surgical
procedure to judge the astinmatism induced in the cornea while putting sutures.
Class of medical device:Class A
Material of construction:Aluminium
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Artificial Anterior Chamber
18 Model No.:NIL
Intended Use:This is a mechanical ophthalmic device used to firmly hold the doner
cornea (14-18mm) on a bed of viscoelastic, inflate it and cut it with the suction
trephine from the epithelial side, cutting from the ophthalmic side products a more
perfect donor to host match which dramatically reduces surgically induced
astigmatism.
Class of medical device:Class A
Material of construction:Titanium, Plastic, Silicone, Polycarbonate
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Flute Handle (Charles)
19 Model No.:NIL
Intended Use:This is an ophthalmic device used for passive aspiration of
intraocular fluids during a Vitreo Retinal Surgery.
Class of medical device:Class A
Material of construction:Aluminium
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Occluder
20 Model No.:Occluder without pin hole - In House ,Occluder with pin hole - In House ,
Occluder multipurpose - In House
Intended Use:This is an ophthalmic device used for examination of eye either with
multiple pinhole/ single pin hole/ without pin hole.
Class of medical device:Class A
Material of construction:ABS
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Slit Lamp Shield
21 Model No.:NIL
Intended Use:This is an ophthalmic device used with a slit lamp to minimize the
risk of Covid-19 infection to the user.
Class of medical device:Class A
Material of construction:Clear Acrylic
Dimension(if any):300mmX300mm
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):NIL

Page 4 of 11
 Generic Name:Eye Shield
22 Model No.:Eye Shield Clear - In house ,Eye Shield Blue - In House
Intended Use:Eye shield is used for a short duration to protect the patient’s eye
from accidental injury or rubbing after a cataract surgery.
Class of medical device:Class A
Material of construction:Polycarbonate, Polypropylene
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Diagnostic Condensing Lens-Aspheric Lenses
23 Model No.:20D Aspheric Lens Brand Opticlear - In House ,78D Aspheric Lens Brand
Opticlear - In House ,90D Aspheric Lens Brand Opticlear - In House
Intended Use:Double Aspheric Lenses are used for general examination of the
fundus using either a Binocular Indirect Ophthalmoscope or a Slit Lamp.
Class of medical device:Class A
Material of construction:Aluminium, Glass
Dimension(if any):Various sizes
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Opticlear
Generic Name:Corneoscleral Punch
24 Model No.:Corneal Trephine - 1 to 20mm ,Suction Trephine - 6 to 20mm ,Trephine
Punch - (6 to 20mm) Vacuum and Non-Vacuum ,Fixed Depth Trephine - 2 mm to 9
mm in 150 µm ,200 µm,250 µm, 300µm,350µm, 400µm blade height,Jacob CAIRS
Trephine - 6.50-8.0 mm, 7.75-8.75 mm, 8.0-9.50 mm
Intended Use:A disposable sterile circular blade used to take out a circular corneal
button of predetermined diameter from the donor or recipient cornea in a corneal
transplant (Keratoplasty) procedure
Class of medical device:Class B
Material of construction:Stainless Steel, Polycarbonate, ABS, Silicone, PVC, Nylon
Dimension(if any):Various sizes
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Nanoedge
Generic Name:Micro Incision Blade
25 Model No.:Lance - (15 to 45°) ,Slit - (1.2 to 4.0mm) ,MVR - (19G,20G - ,23G - ,25G)
- ,Crescent - (1 to 4.0 mm) ,Enlarger - (5.0 to 5.5 mm) ,Micro Incision Blade With
Safety Lance - (15 to 45°) ,Micro Incision Blade With Safety MVR - (19G,20G - ,23G -
,25G) - ,Micro Incision Blade With Safety-Crescent - (1 to 4.0 mm) ,Micro Incision
Blade With Safety-Slit - (1.2 to 4.0mm) ,Micro Incision Blade-Lance Green Blade -
(45°)
Intended Use:Sterile single use micro incision blades for making corneal or sclera
incision during ophthalmic surgical procedures.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene, Polycarbonate
Dimension(if any):Various sizes
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Nanoedge
Generic Name:Iris Retractors
26 Model No.:Iris Retractors - In House ,Dholakia Iris Hook - In House
Intended Use:A disposable set of sterile iris retractors is used for temporary
retraction (pupil enlargement) of the iris during an ophthalmic surgical procedure.
Class of medical device:Class B
Material of construction:Polypropylene, Nylon, Silicone
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Iris Care

Page 5 of 11
 Generic Name:Intraocular Lens Glide
27 Model No.:NIL
Intended Use:A disposable sterile Lens Glide is used for insertion of IOLs or other
microsurgical instruments in the anterior chamber. It is also used for removal of
cataract lens matter from the anterior chamber during an ophthalmic surgical
procedure.
Class of medical device:Class B
Material of construction:Polypropylene
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Temporary Keratoprosthesis
28 Model No.:Temporary Keratoprosthesis 7.5mm 9.0mm - In House
Intended Use:This is a surgical lens which is used to facilitate viewing of the
peripheral retina and the posterior pole during vitrectomy and corneal transplant
surgery.
Class of medical device:Class B
Material of construction:PMMA (Polymethyl methacrylate)
Dimension(if any):7.5mm, 9.00mm
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Opticlear
Generic Name:Capsule Hooks
29 Model No.:Capsule Hook - In House ,Makool Hook - In House
Intended Use:A disposable set of sterile capsule hook is used for temporary
support of capsule bag during an ophthalmic surgical procedure.
Class of medical device:Class B
Material of construction:Nylon, Silicone
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Capsule Care
Generic Name:Pupil Dilator
30 Model No.:3 Loop - In House ,4 Loop - In House ,8 Loop - In House ,6 Loop - In
House
Intended Use:A single use device which is used to mechanically dilate the pupil
during an ophthalmic surgical procedure. This device can be removed after the
surgery thereby restoring the pupil to its original position.
Class of medical device:Class B
Material of construction:Monofilament Polyamide (Black)
Dimension(if any):Various sizes
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Teflon Block
31 Model No.:Teflon Block with hole - In House ,Teflon Block without hole - In House
Intended Use:The corneo sclera tissue is placed over the Teflon Block and the
donor button then punched out. A disposable piece of sterile Teflon Block is used to
put the corneo sclera tissue in its corneal curvature.
Class of medical device:Class B
Material of construction:Teflon
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL

Page 6 of 11
 Generic Name:Buonsanti Dual Hook
32 Model No.:NIL
Intended Use:A disposable set of sterile Buonsanti Dual Hook is used for providing
temporary support to capsular bag and for temporary retraction (pupil enlargement)
of the iris together without making too many incisions. It can be used in cases which
have both zonular instability and small pupil size together.
Class of medical device:Class B
Material of construction:Nylon, Polypropylene, Silicone
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Vitrectomy Infusion Cannula
33 Model No.:20G - In House ,23G - In House
Intended Use:A disposable sterile single use Vitrectomy Infusion Cannula is used
for infusion of irrigation fluids or surgical fluid like silicon oil / PFCL during vitreo-
retina ophthalmic surgical procedure.
Class of medical device:Class B
Material of construction:Stainless Steel, Polycarbonate, Silicone
Dimension(if any):Tip- 2mm, 4.0mm, 6.0mm
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula - Silicone Tip Cannula
34 Model No.:Blunt Tip - In House ,Regular Tip - In House ,Brush Tip - In House ,
Straight Tip - In House ,Green Silicon Tip (Regular/Brush) - In House
Intended Use:A disposable sterile single use Silicone tip Cannula (20G, 23G, 25G,
27G) is used for altraumatic removal of intraocular fluids by active or passive
aspiration during vitreo-retina ophthalmic surgical procedures. Due to a very soft
silicon tip, the device is useful for atraumatic brushing of the retinal surface with
simultaneous aspiration. It is also helpful for repositioning of retinal folds or breaks
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene, Silicone
Dimension(if any):20G, 23G, 25G, 27G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Backflush Flute Needle with Silicone Tip
35 Cannula
Model No.:20G - In House,23G - In House,25G - In House,27G - In House
Intended Use:A disposable sterile Backflush Flute Needle with silicon tip cannula
(20G/23G/25G/27G) is used for altraumatic removal of intraocular fluids by active or
passive aspiration during vitreoretinal ophthalmic surgical procedures with a safety
feature of a backflush reservoir which can be used to reflux back the unwanted
tissue or fluid aspirated during the procedure. Due to a very soft silicon tip, the
device is useful for atraumatic brushing of the retinal surface with simultaneous
aspiration. It is also helpful for repositioning of retinal folds or breaks
Class of medical device:Class B
Material of construction:Stainless Steel, Aluminium, Silicone
Dimension(if any):20G, 23G, 25G, 27G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Anterior Chamber Maintainer
36 Model No.:NIL
Intended Use:A disposable sterile Anterior Chamber Maintainer is used for
maintaining the anterior chamber during an ophthalmic surgical procedure.
Class of medical device:Class B
Material of construction:Stainless Steel, Silicone, PP
Dimension(if any):19G, 20G, 23G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo

Page 7 of 11
 Generic Name:Ophthalmic Cannula- Anaesthesia Cannula
37 Model No.:Peribulbar (Atkinson) - In House ,Retrobulbar - In House ,Sub tenon - In
House
Intended Use:A disposable sterile ophthalmic cannula used for administering local
anaesthesia prior to ophthalmic surgery
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):19G, 21G, 23G, 25G, 27G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Cystotome Cannula
38 Model No.:Formed - In House ,Blumenthal - In House
Intended Use:This is a disposable ophthalmic cannula of different gauge and
needle lengths. This device is supplied sterile in peel open pouches.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):25G, 26G, 27G, 30G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Air Injection & Irrigation Cannula
39 Model No.:Anterior Chamber (Rycroft) - In House ,Viscoelastic - In House
Intended Use:A disposable sterile ophthalmic cannula used for maintaining or
forming anterior chamber and irrigating cornea during surgery. It may be used for
injection and removal of air, fluids, viscoelastic substances and miotics during
ophthalmic Surgery
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):16G, 19G, 20G, 21G, 23G,25G, 26G, 27G, 28G, 30G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Hydrodissection / Hydrodelineation Cannula
40 Model No.:Nucleus Hydrodissection Cannula - In House ,J Shaped Nucleus
Hydrodissection Cannula - In House
Intended Use:A disposable sterile ophthalmic cannula used to effectively separate
layers & nucleus and cortex in cataract surgery procedures. Flatted tip design allows
cannula’s insertion under anterior capsule and distribute fluid in a fan-like manner
for dissection of nucleus from cortex and capsule.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):23G, 25G, 27G, 30G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Cortex Aspirating Cannula
41 Model No.:Cortex Aspirating Cannula - In House ,J Shaped Cortex Aspirating
Cannula - In House
Intended Use:A disposable sterile ophthalmic cannula used for aspirating cortical
debris when chamber is maintained with either an anterior chamber maintainer or a
viscoelastic substance. Curved and ‘J’ shaped cannulas are especially useful for
retracting iris and aspirating difficult to reach cortex between the 10-12 O’clock
meridian during ophthalmic surgery.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):21G, 23G, 25G, 26G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo

Page 8 of 11
 Generic Name:Ophthalmic Cannula- Irrigating & Aspirating Cannula
42 Model No.:NIL
Intended Use:This product is used for maintaining or forming anterior chamber
and irrigating cornea during surgery. It may be used for injection and removal of air,
fluids, viscoelastic substances and meiotic during Ophthalmic Surgery.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene, Silicone
Dimension(if any):21G, 22G, 23G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Capsule Polisher
43 Model No.:Regular - In house ,Olive Tip - In House
Intended Use:This product is used for removing debris from the posterior, anterior
and equatorial regions of capsular bag, micro etched tips are slightly roughened for
gentle polishing. Flexible tip cannulas have a sleeve for atraumatic and removal.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):21G, 23G, 25G, 27G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Lens Removal Cannula
44 Model No.:Irrigating Vectus - In House
Intended Use:This product is used for irrigating and lifting out the lens nucleus and
large cortical debris. Anterior chamber depth is maintained by irrigation through the
port when instrument is attached to a syringe or an I/A machine.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):23G, 25G, 27G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Vitreoretinal Cannula
45 Model No.:PFCL I/A Dual Bore Cannula - In House ,VFI- Blunt Tip Cannula - In house
Intended Use:This product is used for specific procedure in vitreoretinal surgery.
Many of these innovative products have distinct feature including micro tip
extensions and ultra-thin wall cannulas.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):20G/25G, 23G/30G, 23G, 25G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Bimanual Cannula
46 Model No.:Disposable - In house ,Titanium - In House ,Stainless Steel - In House
Intended Use:This instrument is used for irrigation and aspiration of the anterior
chamber
Class of medical device:Class B
Material of construction:Stainless Steel, Plastic, Titanium
Dimension(if any):21G, 22G, 23G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Ophthalmic Cannula- Lasik Cannula
47 Model No.:Lasik Irrigating Cannula (banaji) - In House ,Lasik Double Arm Cannula-
Irrigating by eight Ports (Vidaurri) - In House
Intended Use:This product is used for all types of refractive surgery and minor
office procedure
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):16G, 23G, 25G, 27G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo

Page 9 of 11
 Generic Name:Ophthalmic Cannula- Coaxial Cannula
48 Model No.:CO-Axial I&A handpiece - 23g (Angled) 45 ,CO-Axial I&A handpiece -
21g (Straight) ,CO-Axial I&A handpiece - 21g (Angled) 45 ,CO-Axial I&A handpiece -
23g (Straight)
Intended Use:Disposable ophthalmic cannula used for irrigation and aspiration of
the anterior chamber.
Class of medical device:Class B
Material of construction:Stainless Steel, Polypropylene
Dimension(if any):21G, 23G
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:Cellulose Sponge Spears
49 Model No.:Cellulose Sponge Spears (pack of 5) - In House
Intended Use:A sterile compressed cellulose sponge spear is used to absorb
excess fluids from the corneal / scleral surface or to manipulate tissue during an
ophthalmic surgical procedure.
Class of medical device:Class A
Material of construction:Polypropylene (Green) Compressed Cellulose Sponge
Epoxy Adhesive
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:Backflush Handle (Passive Aspiration)
50 Model No.:NIL
Intended Use:A disposable sterile disposable Backflush Flute Handle (Passive
aspiration) is used for atraumatic removal of intraocular fluids by passive aspiration
during vitreo-retina ophthalmic surgical procedures
Class of medical device:Class A
Material of construction:Aluminium, Silicone
Dimension(if any):Standard Size
Shelflife:Nil
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):Maxiflo
Generic Name:PVA Instruments Wipe
51 Model No.:NIL
Intended Use:used to absorb excess fluids from the corneal / scleral surface or to
manipulate tissue during an ophthalmic surgical procedure
Class of medical device:Class A
Material of construction:POLYVINYL ALCOHOL (PVA)
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:PVA Segment
52 Model No.:Round 9.0mm - In House , 9.5 mm dia - In House ,Rectangle - In House
Intended Use:used to absorb excess fluids from the corneal / scleral surface or to
manipulate tissue during an ophthalmic surgical procedure.
Class of medical device:Class A
Material of construction:POLYVINYL ALCOHOL (PVA)
Dimension(if any):Various sizes
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL

Page 10 of 11
 Generic Name:PVA Sponge Spears
53 Model No.:PVA Sponge Spears (Pack of 5) - In House
Intended Use:A sterile compressed PVA sponge spear is used to absorb excess
fluids from the corneal / scleral surface or to manipulate tissue during an ophthalmic
surgical procedure. A PVA sponge is particularly preferred in the LASIK laser surgery
due to a very soft cell structure when wet.
Class of medical device:Class A
Material of construction:K- RESIN, POLYVINYL ALCOHOL (PVA)
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL
Generic Name:PVA Wick Drain
54 Model No.:PVA Wick Drain (pack of 10) - In House
Intended Use:used to absorb excess fluids from the corneal / scleral surface or to
manipulate tissue during an ophthalmic surgical procedure.
Class of medical device:Class A
Material of construction:POLYVINYL ALCOHOL (PVA)
Dimension(if any):Standard Size
Shelflife:5 years
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):NIL

ANIL Digitally signed

by ANIL KUMAR
KUMAR NEGI
Date: 2023.09.18
Place: NEGI 18:01:17 +05'30'
Date:18-Sep-23 State Licensing Authority
Govt. of NCT of Delhi
Delhi - 110032

Page 11 of 11