Your reference: Kaja Shahin

Our reference: 1 O27 1 9050

§tr&r; §smedic Team Export Certificates, e-mail: fsc@swissmedic.ch
Page 1/1

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Berne, December 14, 2023

swfssrnedic
Confirmation letter for the Health Authorities of Golombia

To whom it may concern,

The SWISS AGENCY FOR THERAPEUTIC PRODUCTS, SWISSMEDIC, authorizes and

supervises therapeutic products (medicinal products and medical devices). ln Switzerland
medical deVices are regulated under the Federal Act on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA; SR 812.21) and the Medical Devices Ordinance (MedDO; SR
812.213).
On the basis of the documents submitted, Swissmedic confirms that the products specified
hereunder and manufactured by the company Scanderra GmbH, Staenzlergasse 7, 4051 Basel
do not meet the definition of a medical device according to the TPA and the MedDO. Therefore
the Agency cannot issue an export certificate for these products.
- See attached list of 001 page

Yours sincerely,

Spissmedic, Swiss Agency for Therapeutic Products

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Ändrea Bo#hung

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Contact person:
Market Surveillance Sector, Division Medical Devices Operations and Hospitals
Team Export Certificates, e-mail: fsc@swissmedic.ch

Annexes mentioned

Schweizerisches Heilmittelinstitut
lnstitut suisse des produits thörapeutiques
lst:iuto svizzero per gli agenti terapeutici Print No. - 203.16516 - eaoe uz
Swiss Agency for Therapeutic Products ffi
SwissmeCic I Hällerstrasse 7 13012 Bern l Schr,veiz l www.swissmedic.ch I Tel. +41 58462 01 11 | Fax +41 5846202 12
 1t1

Gesuchsteller/ Product Owner:

Scanderra GmbH
Staenzlergasse 7
/ 4051 Basel
Switzerland

Ref.: Ref.: Brand Product Name as on packaging

Art--No Art.Name

lnterdental Brushes
100242 EW-tD7.25 edel+white SSS 0.45mm in baq BULK 25 pcs
100243 EW-ID7 25 edel+white SS 0.5mm in bao BULK 25 ocs
100244 w-1D7.25 edel+white S 0.6mm in baq BULK 25 pcs
100245 EW-1D7.25 edel+white M 0.7mm in baq BULK 25 pcs
100246 EW-1D7.25 edel+white L 0.8mm in baq BULK 25 pcs
100247 EW-tD7.25 edel+white XS 0.4mm in bao BULK 25 ocs
300331 EW-ID7-XS edel+white lnterdental Brush O.42mm 6pcs in PP box
300332 EW-ID7-SSS edel+white lnterdental Brush 0.45mm 6pcs in PP box
300333 EW-ID7-SS edel+white lnterdental Brush 0.5mm 6pcs in PP box /.§-/aml**\
300334 EW.ID7-S edel+white lnterdental Brush 0.6mm 6pcs in PP box
300335 EW-ID7-M edel+white lnterdental Brush 0.7mm 6pcs in PP box
300336 EW-ID7-L edel+white lnterdental Brush 0.8mm 6pcs in PP box
300337 EW-ID7-A edel+white lnterdental Brush assorted 6pcs in PP box
Manual Toothbrushes
1001 05 EW-VSD2 edel+white Duo Flosserbrush Ultrasoft, SWISS loqo, 2 caps, PET box
100'108 EW-VSD edel+white Ultrasoft Flosserbrush SWISS in PET box
1 001 09 EW.VSDF edel+white Flosserbrush Ultrasoft in foil
100111 EW-K3D edel+white Kids Flosserbrush Ultrasoft in blister
100114 EW-VD edel+white Soft lntensive Flosserbrush SWISS in PET box
1001'19 EW-VW edel+white Eraser Whitening toothbrush in PET box
I 001 29 EW-CC edel+white GleanCurl Curved toothbrush in blister
1 001 31 EW-ORTHO edel+white Pro Ortho Toothbrush
100256 EW-GUMP edel+white Pro Gums Toothbrush
100278 EW-GUMP24 edel+white Pro Gums Toothbrush BULK, 24 pcs in inner box
Dental Floss
800829 EW-PC7O edel+white Easy Tape Waxed Dental Tape Caipirinha in blister 70m
800830 EW.PLTO edel+white Easy Tape Waxed Dental Tape oranoe in blister 70m
800852 EW-EF25 edel+white Expanding Supefloss 25m in blister
800853 EW-XF50 edel+white Supersoft Floss 50 strands

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