How to Use

This guidance explains the individual information to be filled which is necessary for TÜV SÜD Product Service
for assessment of IVDR Conformity Assessment Application.
Please prepare this document f or each IVDR Conformity Assessment (Annex IX, Annex X or Annex XI), if
applicable. If only Annex IX is applicable for conformity assessment, only this single document need to be
prepared.
Prepare this document in relation to applied scope of QMS and products to be covered under respective IVDR
confromity assessment as described above.
Please complete the tabs " Sheet 0 - Basic Information ", "Sheet A - List of devices", "Sheet B - Sites" and
"Sheet C - Suppliers and subcontractors".

0-Basic Information Example

Appendix Reference No.: Please add a document identification number e.g. DOC123 Doc 123
Populated automatically in other data sheets
Version: Add current document version Ver. 01
Populated automatically in other data sheets
Legal Manufacturer: Name of legal manufacturer with legal entity e.g. Company GmbH Company GmbH
If more than one site applicable add legal manufacturer main site
Client Number: Please add here your client no. If you do not know it, it is in every 12345
certification no. between certification type and revision e.g. V12
12345 XXX
Application Identification: Used to identify the electronic application CA-YYYY-12345-01
In case of existing clients have assigned client number, which should
instead of xxxxx. In case of new client without assigned client number
for initial application should use short name instead of xxxxx.
Application for new conformity assessment certificate
Format: CA-YYYY-xxxxx-n, Example: CA-2021-12345-1
Application for substantial change(s)
Format: CN-YYYY-xxxxx-n, Example: CN-2021-12345-1
Application for recertification/Renewal
Format: RC-YYYY-xxxxx-n, Example: RC-2021-12345-1
In case of multiple selection within application
Format: CA_CN-YYYY-xxxxx-n, Example: CA_CN-2021-12345-1

Type of Conformity Assessment: Select type of conformity assessment (Annex IX, Annex X or Annex XI)

Respective TÜV SÜD EU Certificates:
UDI-Issuing Entity
See Column T & U in Sheet A - List of devices
By Commission Implementing Decision (EU) 2019/939, 4 issuing
entities were designated to provide manufacturers with a list of UDIs
to assign on medical devices. Provide the Name of the Issuing Entity
for the UDI you choose

Additional Information: Field if any additional information needs to be added

Version History: Please use the version history to add information on changes - This
infomation helps to track the QMS and Products related changes after
initial conformity assessment

A - List of devices Example

# Assign a number to the entry, for easy referencing on Sheet B #1
Device Name Add device name (Trade name) under which it is placed on the IVD Reagent
market/sold IVD Control
Please add all the name of product variants covered under one Basic IVD Calibrator
UDI-DI in same field, if the product variants differ in name

Reference No. Provide Article No. / List No. / Ref. No. refering to respective product RXN 1001
Please add all the Article No. / List No. / Ref. No. to respective CTRL 1002
product variants covered under once Basic UDI-DI in same field CAL 1003

Basic UDI-DI Basic UDI-DI 1

Mandatory information f or registration and certification of devices
under Regulation (EU) 2017/746
In case of class B and class C device, the Basic UDI-DI is an important
information to calculate the sampling size
Please refer to: MDCG 2018-1 and MDCG 2019-13
Class Select risk Class of IVD device - e.g. Class B, C, D, As Class B
In case of Class A Sterile device select respective sterilization
technology as provided in dropdown
Rule 1
Select applicable rule (most appropriate indent) based on the
intended purpose of the device. according to Regulation (EU)
2017/746 - Annex VIII Classification rules
Please refer to: MDCG 2020-16
Device Type Select applicable device type in order to identify the applicable PLU
conformity assessment routes under applicabale Annex
PLU: Profesional use laboratory device, ST: Self-testing, NPT: Near
patient testing, CDx: Companion diagnostics
In case of combination of PLU, ST and NPT: use following option PLU
& ST, PLU & NPT, ST & NPT, PLU, ST & NPT

EMDN (General) European Medical Device Nomenclature (Former CND coding)Please refer to Category W for IVD device: Traduzione in lingua inglese: Classificazione nazionale dei Dispositivi Medici

EMDN code Level 3 Select EMDN code level 3 e.g. W0101 W0101
Information required to identify generic device group for class C and
define the scope of the EU QMS Certificate
Full EMDN code Add lowest applicable EMDN code level e.g. W01010101 W01010101

IVDR code (General) Please refer to COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185

Please refer to MDCG 2021-14

The IVDR codes should be selected according to the order in
Regulation 2017/2185. The information IVDR codes is required for NB
in order to allocate appropriately qualified and authorised personnel
to carry out audit activities (IVT codes, IVR and certain IVS) or product
reviews (IVR, IVP, IVS and IVD codes).

IVR code(Device category)
Codes reflect the design and intended purpose of the device 0501
Add Exactly 1 IVR code per device. If more than 1 IVR code is
applicable, the one that is first in the list should be selected.
e.g There could be two IVR Code IVR 0501 and IVR 0503 applicable
to Toxoplasma due to specific indended purpose, then only IVR 0501
code should be assigned.

IVS code(s) Assign all codes applicable to the device, thet reflects the specific 1001
characteristics of the device
0 to several IVS code per device possible. e.g. 1001, 1004…etc
IVP code (most appropriate) Select the most appropriate code which describes the main 3002
examination procedures. It is required in case of Class C device to
identify generic device group. e.g. 3001
Exceptional cases may exist that no IVP code is assigned (e.g. controls
or specimen receptacles)

IVP code (all others) Assign additonal IVP code only in cases, where the main examination 3013
procedure can not be covered thorugh most approriate IVP code
only. In this case additional IVP code is needed for selection of
appropriate assessor at NB

IVD code(s) Assign the codes which describe the main laboratory and clinical 4001
disciplines. e.g. 4001
Most approriate IVD code should be assigned to device. Only in
exceptional case e.g. Multiplex device more than one IVD code can
be assigned

IVT code(s) Assign the codes which describe the main production technologies
considering the most critical technologies or production steps
e.g. 2005, 2009

Generic device group (Class C only) This field is filled automatically! W0101 + IVP 3002

Device specifics Select device specifics such as Reagent, Contol, Calibrator, Kit, System, Kit
Instrument, Medical device software (MDS W) or Consumables.

Intended purpose of the device Add intended purpose according to IFU

‘intended purpose’ means the use for which a device is intended
according to the data supplied by the manufacturer on the label, in
the instructions for use, in the performance evaluation or in
promotional or sales materials or statements.
The classification of a device is defined by its intended purpose, as
specified by the manufacturer. It is therefore important that the
manufacturer clearly indicates the purpose for which the device is
intended!

Respective EU-TDA certificate
EU-TDA Certificates are available only for Self- testing, Near-patient V70 XXXX XXXXX,
teasting, Companion diagnostics a Class D Device in conjunction with Rev. XX
respective EU QMS Certificate (V10 XXXX XXXXX, Rev. XX)
Add "TBD", in case of initial IVDR conformity assessment
If certificates are already available, add repective EU-TDA Certificate
(e.g. V70 XXXX XXXX, Rev. XX)

Respective EU-QMS certificate
Added on date (YYYY-MM-DD)
Site #, If more than one site
Add "TBD", in case of initial IVDR conformity assessment V10 XXXX XXXX,
If certificates are already available, add respective EU-TDA Certificate Rev. XX
(e.g. V10 XXXX XXXX, Rev. XX)
Add date of device entry YYYY-MM-DD
Add applicable Site No. to respective device according to Sheet B-Sites Site 1

Supplier ID (Sup #) Assign Supplier ID in accordance to Appendix C Sup 1

B - Sites related to products listed in App-A List of devices Example

Company Name General information on site for contact

Full Postal Address
Country
Name of Person responsible for
regulatory compliance (PRRC)
Contact Person incl. Function
Contact E-Mail
Contact Phone
Products Refer to column W of App A-List of devices
Total Number of Employees: Effective number of employees required f or audit time calculation

Number of Shifts: General shift realted information required for audit planning activities 2
Employees per Shift 100/50
(Shift 1 / Shift 2 / Shift 3):
Seasonal Variations YYYY-MM-DD to
Site shutdown from.. To.. YYYY-MM-DD
Processes / Subsystems Select applicability
Information required for effective planning of audit programme

Appendix C - Critical Supplier and Subcotractors related to products listed in App-A List of devices Example
A critical supplier delivers materials (raw or processed), components (including hardware and software), or
services, that may influence the safety and performance of the product.
The following is a non-exhaustive list of examples of critical suppliers:
Suppliers that carry out all stages of production and supply on behalf of the manufacturer: Sterilization,
Production, Product Testing, OEM Manufacturers, Mechanical Parts and Components, Electrical Parts and
Components, Software for Specified Use, Single Use Parts and Components, F inished Medical Device, Design/
Development, Document Archiving, Transport/ Storage, Environmental Monitoring, Calibration, Consultant
The control measures of a critical supplier can include combination of following non-exhaustive activities:
Supplier audits, Testing/ Verification, Certificates of Analysis / Conformity, Third party certificate (Complete
certificate details columns), Process validations, Statistical process control, Correction, reworking, Inventory
control, Traceability, Change Control (changes to process, parts, procedures, etc. regardless of who initiated),
Configuration management, Protection of intellectual property, Protection of patient information, Document
retention periods, Quality system records, Quality agreement
In cases when the manufacturer is not able to give satisfactory evidence to the audit team that purchased
product or services meet the specified requirements, the auditing organization may need to audit the control
of processes on the premises of the manufacturer's suppliers.

Sup ID Assign a number to supplier entery Sup 1

Company name and address Add full name and physical address of supplier

Legal Manufacturer's Sites where this For Legal Manufacturer's Sites, the numbering based on App B -Sites Site 1
supplier is applicable
Product, component, Provide information on stages perf ormed at this site or services 1, 2, 3
process or service provided provided for which devices f rom App A - List of devices
or key process outsourced
Potential Impact of Outsourced Process Select applicable processes. Use additional information field to
provide other information on outsourced process
Controls Applied at the Legal Select applicable controls applied at the legal manufacturer. Use
Manufacturer additional information field to provide other information about
controls
For critical supplier, sole existence of a certificate against ISO 13485 is
not sufficient as a supplier control measure!

Supplier Certificate Info
Please provide a copy of the quality management certificate held by
the supplier and/or
subcontractor for the products, components and/or services supplied.
The provided certificate should fulfill the following requirements:
- The certificate should be issued to the supplier/subcontractor
identified in this section.
- The certificate should be a valid ISO 13485 certificate.
- The scope of the certificate should cover the products, components
and/or services
supplied.
- The certification body issuing the certificate should be accredited by
an IAF accreditation
body member.
In cases where the supplied certificate does not comply with the
above requirements, its
appropriateness will be reviewed to determine if a supplier audit is
required
 ID 10718
Doc No MEDF0326.01
Revision 2
Status released
Effective Date 26 Aug 2021

Appendix Reference No.:

Version: 00000
Certificate Holder/Legal Manufacturer: Molbio Diagnostics Private Limited
Client number (Legal manufacturer): 84208
Single Registration Number: IN-MF-000028386
Application Identification: MD/IVDR/2022
Type of Conformity Assessment: Annex IX - Conformity assessment, based on a QMS and on assessment of TD
Respective TÜV SÜD EU Certificates: See Column T & U in Sheet A -List of devices
UDI-Issuing Entity: GS1
Additional Information: NA

Version History
Ver. Nr.: Date Author (Function) Reason for Change
[YYYY-MM-YY] Example: Tech File Updated, Code Change, New Model Numbers Added, etc

Ver. 0 2/23/2023 Dr. Sivakumar Selvaraj Initial Introduction of device list

Ver. 1
Ver. 2
Ver. 3
Ver. 4
Ver. 5
Ver. 6
Ver. 7
Ver. 8
Ver. 9
Ver. 10
Ver. 11
Ver. 12
Ver. 13
Ver. 14
Ver. 15
Ver. 16
Ver. 17
 Appendix Reference No: 0 Details on IVD Devices under Conformity Assessment Procedure in Accordance with IVDR Last verified on:

Verified by NB -
Version: 0 Assessor:

Information
Generic device Added on Site #, If Supplier Verified by
# Device Name Ref No. Basic UDI-DI Class Rule Device Type EMDN code EMDN code (most IVR code IVS IVP code IVP code IVD IVT Device specifics Intended purpose of the device Respective EU-TDA certificate Respective EU-QMS more
date (YYYY- than TÜV SÜD on internal comments by PH/CARE
Level 3 granular level) (Device
code(s) (most
(all others) code(s) code(s) group certificate one ID (Sup {yyyy-mm-dd} {Name}
category) appropriate) (Class C only) MM-DD) site #) (To be filled
by NB)
1 Truenat® CT MD/IVDR/CT/2022 8908007989491CM C 3a PLU & NPT W0105 W0105010117 IVR0503 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® CT is a chip-based Real Time Polymerase Chain TBD EN ISO 13485:2016 - Q5 084208 2019/06/12 Site 1 ,Site Sup/01,
Reaction (PCR) test for the semiquantitative detection 0004 Rev.00 4 Sup/02,
of Chlamydia trachomatis in female endocervical and Sup/03,
vaginal swab specimens, male urethral swab specimen Sup/04,
and male and female Urine specimen. It aids in the Sup/05,
diagnosis of symptomatic or asymptomatic infection SUP/06,
with Chlamydia trachomatis. Truenat® CT runs on the SUP/07,
Truelab ® Real Time micro PCR Analyzers. SUP/08
SUP/09

2 Truenat® HPV-HR MD/IVDR/TN/2022 8908007989705CM C 3h PLU & NPT W0105 W0105041002 IVR0302 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® HPV-HR is a chip-based Real Time Polymerase TBD EN ISO 13485:2016 - Q5 084208 2019/06/12 Site 1 ,Site Sup/01,
Chain Reaction (PCR) test for the semi quantitative 0004 Rev.00 4 Sup/02,
detection of high risk Human Papillomavirus (HPV) types Sup/03,
16, 18, 31 and 45 in female cervical specimens collected Sup/04,
by a clinician. It aids in the differential diagnosis of Sup/05,
symptomatic or asymptomatic infection with high risk SUP/06,
HPV types 16, 31 and 18, 45. Truenat® HPV-HR runs on SUP/07,
the Truelab Real Time Quantitative micro PCR Analyzers. SUP/08
SUP/09

3 Truenat® MTB MD/IVDR/TB/2022 8908007989064BW C 3b PLU & NPT W0105 W0105010799 IVR0504 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® MTB is a chip-based Real Time Polymerase TBD EN ISO 13485:2016 - Q5 084208 2019/06/12 Site 1 ,Site Sup/01,
Chain Reaction (PCR) test for the quantitative detection 0004 Rev.00 4 Sup/02,
and diagnosis of Mycobacterium tuberculosis (MTB) in Sup/03,
human pulmonary and EPTB specimen and aids in Sup/04,
thediagnosis of infection with MTB. Truenat® MTB runs Sup/05,
on the Truelab® Real Timemicro PCR Analyzers. SUP/06,
SUP/07,
SUP/08
SUP/09

4 Truenat® MTB Plus MD/IVDR/TP/2022 8908007989460CA C 3b PLU & NPT W0105 W0105010799 IVR0504 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® MTB Plus is a chip-based Real Time TBD EN ISO 13485:2016 - Q5 084208 2019/06/12 Site 1 ,Site Sup/01,
Polymerase Chain Reaction(PCR) test for the semi 0004 Rev.00 4 Sup/02,
quantitative detection and diagnosis of Mycobacterium Sup/03,
tuberculosis (MTB) in human pulmonary (sputum/non- Sup/04,
sputum) and EPTB specimen and aids in the diagnosis of Sup/05,
infection with MTB. Truenat® MTB Plus runs on the SUP/06,
Truelab® Real Time Quantitative micro PCR analyzers. SUP/07,
SUP/08
SUP/09

5 Truenat® MTB RIF-Dx MD/IVDR/TX/2022 8908007989675CZ C 3b PLU & NPT W0105 W0105010799 IVR0504 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® MTB-RIF Dx is a chip-based Real Time TBD EN ISO 13485:2016 - Q5 084208 2019/06/12 Site 1 ,Site Sup/01,
Polymerase Chain Reaction (PCR) test for the detection 0004 Rev.00 4 Sup/02,
of Rifampicin resistance in Mycobacterium tuberculosis Sup/03,
(MTB) in Truenat® MTB/MTB Plus positive human Sup/04,
specimen and aids in the diagnosis of MDR-TB. This test Sup/05,
detects the presence of major mutations (SNPs) in the SUP/06,
MTB genome that are known to cause resistance to SUP/07,
rifampicin. Truenat® MTB-RIF Dx runs on the Truelab® SUP/08
Real Time Quantitative micro PCR Analyzers. This is a SUP/09
follow on test, to be performed only on the extracted
DNA from Truenat® MTB/MTB Plus positive sample.

6 Truenat® CDI MD/IVDR/CS/2022 890800798989DT B 6 PLU & NPT W0105 W0105011602 IVR0504 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® CDI is a chip-based Real Time Polymerase TBD EN ISO 13485:2016 - Q5 084208 2022/10/11 Site 1 ,Site Sup/01,
Chain Reaction (PCR) test for the semi-quantitative 0004 Rev.00 4 Sup/02,
detection and diagnosis of Clostridium difficile infections Sup/03,
in stool samples. Truenat® CDI runs on the Truelab® Sup/04,
Real Time Quantitative micro PCR Analyzers. Truenat® Sup/05,
CDI is an in vitro diagnostics test meant for professional SUP/06,
use only. SUP/07,
SUP/08
SUP/09

7 Truenat® CT/NG MD/IVDR/NC/2022 8908007989552CG C 3a PLU & NPT W0105 W0105010117 IVR0503 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® CT/NG is a chip-based Real Time Polymerase TBD EN ISO 13485:2016 - Q5 084208 2019/06/12 Site 1 ,Site Sup/01,
Chain Reaction (PCR) test for the semi quantitative 0004 Rev.00 4 Sup/02,
detection of Chlamydia trachomatis and Neisseria Sup/03,
gonorrhoeae in female endocervical and vaginal swab Sup/04,
specimens, male urethral swab specimen and male and Sup/05,
female Urine specimen. It aids in the diagnosis of SUP/06,
symptomatic or asymptomatic infection with Chlamydia SUP/07,
trachomatis and Neisseria gonorrhoeae. Truenat® SUP/08
CT/NG runs on the Truelab® Real Time micro PCR SUP/09
Analyzers.

8 Truenat®MTB-INH MD/IVDR/IN/2022 89080201397295F C 3b PLU & NPT W0105 W0105010799 IVR0504 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® MTB-INH is a Chip-based Real Time TBD EN ISO 13485:2016 - Q5 084208 2023/01/09 Site 1 ,Site Sup/01,
Polymerase Chain Reaction (PCR) test for the detection 0004 Rev.00 4 Sup/02,
of Isoniazid resistance in Mycobacterium tuberculosis Sup/03,
(MTB) in Truenat® MTB/MTB Plus positive human Sup/04,
specimen and aids in the diagnosis of MDR-TB. This test Sup/05,
detects the presence of major mutations (SNPs) in the SUP/06,
MTB genome that are known to cause resistance to SUP/07,
Isoniazid. Truenat® MTB-INH runs on the Truelab® Real SUP/08
Time Quantitative micro PCR Analyzers. This is a follow SUP/09
on test, to be performed only on the extracted DNA
from Truenat® MTB/MTB plus positive sample. Truenat®
MTB-INH is an in vitro diagnostics test meant for
professional use only.

9 Truenat® HCV MD/IVDR/HC/2022 8908007989613CB D 1 PLU & NPT W0105 W0105020307 IVR0504 IVS1001 3011 NA IVD4009 IVT2011 W0105 + IVP 3011 Kit Truenat® HCV is a chip-based Real Time Reverse TBD EN ISO 13485:2016 - Q5 084208 2019/09/12 Site 1 ,Site Sup/01,
Transcription Polymerase Chain Reaction (RT-PCR) test 0004 Rev.00 4 Sup/02,
for the quantitative detection of Hepatitis C virus (HCV) Sup/03,
RNA in human plasma, serum and whole blood samples. Sup/04,
Truenat® HCV aids in the diagnosis and confirmation of Sup/05,
HCV infection (in conjunction with HCV antibody test) SUP/06,
and in estimation of viral load. It is not intended as a SUP/07,
blood donor screening test. Truenat® HCV runs on the SUP/08
Truelab®Real Time micro PCR Analyzers. SUP/09

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+ IVP
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+ IVP
+ IVP
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+ IVP
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+ IVP
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+ IVP
+ IVP
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+ IVP
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+ IVP
+ IVP
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+ IVP
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+ IVP
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+ IVP
+ IVP
+ IVP
+ IVP
+ IVP
+ IVP
+ IVP
+ IVP
+ IVP
+ IVP
Appendix Reference No: 0 Details on all Sites covered by the same Quality
Version: 0
Management System

Site 1 Site 2
(Legal Manufacturer) (Additional Site)

Company Name Molbio Diagnostics Private Limited Molbio Diagnostics Private Limited

Plot No.L-46 phase II D, Verna Industrial Estate, Plot No.2 nd floor, golden Heights, 59 th
Street & No.
Verna ‘C’ Cross, 4 th M Block, Rajaji Nagar,
Bengaluru-560010, India
Full Postal Address
Zip Code 403722 560010
City Verna Bengluru
Country India India
Name of PRRC Dr. Sivakumar Selvaraj Dr. Sivakumar Selvaraj
Dr. Sivakumar Selvaraj (Management Mr. Shaithilya (Management Representative)
Contact Person incl. Function Representative)
Contact E-Mail drsivakumar@molbiodiagnostics.com shaithilya.an@bigtec.co.in
Contact Phone (+91)7823027271 (+91)9880537767
Total Number of Employees: 146 3
Number of Shifts: 1 1
Employees per Shift NA NA
(Shift 1 / Shift 2 / Shift 3):
Seasonal Variations NA NA
Site shutdown from.. To..
Top Management / QM / Admin Applicable Applicable
Regulatory Affairs Applicable N/A
Design and Development N/A Applicable
Production and Process Controls Applicable N/A

Processes / Product Documentation Applicable N/A

Subsystems Purchasing Controls, incl. Verification of
Purchased Devices Applicable N/A
Corrective and Preventive Actions, incl.
Post-Market Surveillance Applicable N/A
Post-Market Performance Follow-up
(PMPF) Applicable N/A

Others, please specify N/A N/A

 Appendix Reference No.: 0 Details on Suppliers and Subcontractors that Significantly influence the conformity of finished devices
Version: 0 (Conformity Assessment Procedure in accordance with Regulation (EU) 2017/746 (IVDR))
Basic Information Potential Impact of Outsourced Process TÜV SÜD Assessment of Critical Supplier Controls (To be filled by TÜV SÜD)
Outsourced process Controls Applied at the Legal Manufacturer (Select all that apply; If additional controls are in place that are not available in the choices, place them in the additional information.) Supplier Assessment / Audit Status by TÜV SÜD Product Service / Justification
Does the scope
Additional Information about cover the Supplier Audit Required
Supplier Legal Manufacturer's Sites Additional Information Expiration Date of (if Yes, transfer Last TÜV SÜD Comments/Input
Company name Complete address Outsources Process / Critical NB/CB issuing the certificate Standard Certificate # products/ Audit Frequency (if
ID where this supplier is applicable Process 1 Process 2 Process 3 Process 4 Supplier Control 1 Control 2 Control 3 Control 4 Control 5 Control 6 Control 7 about Controls
processes that are
certificate information in special Supplier Audit (if Justification for Audit or No from TDA (last
Audits Tab of Applicable) Applicable) Audit (if applicable) assessment, project
outsourced? no...etc.)
assessment plan)
1. Supplier Evaluation and BSI ISO 9001: 2015, ISO 9001: 2015 - FM 590012
2199 SOUTH MCDOWELL, BOULEVARD PETALUMA, Third party certificate Approval ISO 13485:2016 ISO 13485:2016 - FM 592939
Certificates of Analysis / 2.Supplier Rating
SUP/01 LCG BIOSEARCH TECHNOLOGIES A/S CA 94954-6904, USA VOLDBJERGVEJ Site 1, Site 4 N/A N/A N/A N/A Supplier of Oligonucleotides Supplier audits Testing/ Verification Conformity (Complete certificate details Quality agreement N/A N/A N/A 5/1/2023
16B, DK-8240 RISSKOV, DENMARK columns)

1. Supplier Evaluation and BSI ISO 13485:2016 ISO 13485:2016 certificate No. MD
Third party certificate Approval 642790
SUP/02 THERMO
UAB
FISCHER SCIENTIFIC BALTICS V. A. GRAICIUNO 8, LY-02241, VILNIUS LITHUANIA Site 1, Site 4 N/A N/A N/A N/A Supplier of Chemicals and Ezymes Supplier audits Testing/ Verification Certificates of Analysis /
Conformity
(Complete certificate details Quality agreement N/A N/A 2.Supplier Rating N/A 5/22/2024
columns)

PLOT NO-12, BOMMASANDRA JIGANI LINK RD, Third party certificate 1. Supplier Evaluation and IQNET ISO 9001:2015 DE-005356 QM15
Certificates of Analysis / Approval
SUP/03 SIGMA ALDRICH, MERCK B0MMASANDRA INDUSTRIAL AREA BENGALURU, Site 1, Site 4 N/A N/A N/A N/A Supplier of Chemicals Supplier audits Testing/ Verification Conformity (Complete certificate details Quality agreement N/A N/A
2.Supplier Rating
N/A 11/23/2023
KARNATAKA 560099 columns)

Third party certificate 1. Supplier Evaluation and DNV ISO 13485:2016 250569-2017-AQ-NOR-NA-PS
Certificates of Analysis / Approval
SUP/04 ARTIC ZYMES AS SYKEHUSVEIEN 23, TROMSO 9019, NORWAY Site 1, Site 4 N/A N/A N/A N/A Supplier of Enzymes Supplier audits Testing/ Verification Conformity (Complete certificate details Quality agreement N/A N/A
2.Supplier Rating
N/A 2/18/2025
columns)

Third party certificate 1. Supplier Evaluation and TUV SUD SOUTH ASIA PRIVATE LIMITED ISO 9001:2015 99 100 03285
SUP/05 DANLAW ELECTRONICS ASSEMBLY LTD -L-15,
GOA
VERNA INDUSTRIAL ESTSTE, VERNA, SALCETTE
Site 1, Site 4 N/A N/A N/A N/A Supplier of Truenat® Blank Chips Supplier audits Testing/ Verification Certificates of Analysis /
Conformity (Complete certificate details Quality agreement N/A N/A Approval
2.Supplier Rating
N/A 8/29/2024
columns)

Third party certificate 1. Supplier Evaluation and BUREAU VERITAS ISO 9001:2015 Certificate No. IND.22.9830/QM/U
347, D1 AND D2, KIADB, ELECTRONIC CITY HEBBAL Certificates of Analysis / Approval
SUP/06 CYIENT INDUSTRIAL ESTATE, MYSORE 570016, INDIA Site 1, Site 4 N/A N/A N/A N/A Supplier of Truenat® Blank Chips Supplier audits Testing/ Verification Conformity (Complete certificate details Quality agreement N/A N/A
2.Supplier Rating
N/A 8/18/2025
columns)
1. Supplier Evaluation and STAUNCHLY MANAGEMENT AND ISO 13485:2016 IN53276H
1. GLOBAL INNOVATION PARK, PLOT NO: CP-07, Approval SYSTEM SERVICES LIMITED
SECTOR-08, IMT MANESAR, GURUGRAM -122050, Third party certificate 2.Supplier Rating
Certificates of Analysis /
SUP/07 VVDN TECHNOLOGIES PRIVATE LIMITED HARYANA, INDIA 2. PRODUCT MANUFACTURING Site 1, Site 4 N/A N/A N/A N/A Supplier of Truenat® Blank Chips Supplier audits Testing/ Verification Conformity (Complete certificate details Quality agreement N/A N/A N/A 9/30/2023
PARK, PLOT NO: CP-441, SECTOR-08, IMT MANESAR, columns)
GURUGRAM -122050, HARYANA, INDIA

Federal Agency for Medical and Health

SUP/08 Qarad EC-REP BV PAS 257, 2440 GEEL, BELGIUM Site 1, Site 4 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Products (FAMHP) N/A N/A N/A
1. Supplier Evaluation and ISO 13485:2016-STAUNCHLY ISO 13485:2016 ISO 13485:2016 Certificate No :
Approval MANAGEMENT AND SYSTEM SERVICES ISO 9001:2015 IN52543H ISO 13485:2016 -
9/54, KIRTI NAGAR INDUSTRIES AREA, NEW DELHI - Certificates of Analysis / Third party certificate 2.Supplier Rating LIMITED ISO 9001:2015 Certificate 2023-06-04
SUP/09 Genetix Biotech Asia Pvt. Ltd 110 015, INDIA Site 1, Site 4 N/A N/A N/A N/A Supplier of Nucleotides Supplier audits Testing/ Verification Conformity (Complete certificate details Quality agreement N/A N/A Registration No. QM 04 00420 N/A ISO 9001:2015 -
columns) ISO 9001:2015-TÜV INDIA PVT. LTD 2023-03-28
Yes
Supplier audits