EU Quality Management System CertificateRegulation (EU) 2017/746, Annex IX Chapter I and III

IVDR 752178 R000
IVDR 752178 R000
Manufacturer: Invivoscribe Inc
Address:

10222 Barnes Canyon RdBldg. 1
San Diego
California
92121
USA
Single Registration Number: US-MF-000011736
EU Authorised Representative: Invivoscribe Technologies, SARL
Address:

c/o Ficorec Domiciliation Services132, Boulevard Michelet
Hall Nord - 5ème étage13008 MarseilleFranceScope: See attached Device ScheduleOn the basis of our examination of the quality system in accordance with Regulation (EU) 2017/746, Annex IX
Chapter I and III, the quality system meets the requirements of the Regulation. For the placing on the market ofClass D devices, and self-test, near-patient test and companion diagnostic devices an Annex IX Chapter II certificate
is required.

For and on behalf of BSI, a Notified Body for the above Regulation (Notified Body Number 2797):

Graeme Tunbridge, Senior Vice President Medical Devices
FirstFirst Issue
Issue Date:
Date: 2023-05-07
2023-05-07

Starting
Starting Validity
Validity Date:
Date: 2024-03-04
2024-03-04

Current
Current Issue
Issue Date:
Date: 2024-03-04
2024-03-04

ExpiryExpiry Date:
Date: 2028-05-06
2028-05-06

Page 1 of 3
Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated
through the required surveillance activities of the Notified Body.
This certificate was issued electronically and is bound by the conditions of the contract.
NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80
Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK.
A Member of the BSI Group of Companies.

EU Quality Management System CertificateRegulation (EU) 2017/746, Annex IX Chapter I and III

IVDR 752178 R000
Device Schedule: Class D, C and B devices
Class C Companion Diagnostic Devices
LeukoStrat® CDx FLT3 Mutation Assay

Intended purpose
See IVDR 752181

First Issue Date: 2023-05-07

Starting Validity Date: 2024-03-04

Current Issue Date: 2024-03-04

Expiry Date: 2028-05-06

Page 2 of 3Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated
through the required surveillance activities of the Notified Body.
This certificate was issued electronically and is bound by the conditions of the contract.
NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80
Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK.
A Member of the BSI Group of Companies.

EU Quality Management System CertificateRegulation (EU) 2017/746, Annex IX Chapter I and III

IVDR 752178 R000

Certificate History(References to applicable Common Specifications, Harmonized Standards complied with, and the relevant test and audit reports that support
any of the below certificate changes may be requested from Certificate.Verification@bsigroup.com)

Date2023-05-07
Current

Reference Number
347759430028492

ActionIssuedAmended- EU Authorised Representative address updated.

First Issue Date: 2023-05-07

Starting Validity Date: 2024-03-04

Current Issue Date: 2024-03-04

Expiry Date: 2028-05-06

Page 3 of 3
Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated
through the required surveillance activities of the Notified Body.
This certificate was issued electronically and is bound by the conditions of the contract.
NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80
Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK.
A Member of the BSI Group of Companies.