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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

22.09.2026 04:45

Sync status

Successful

Device

3478287

Actor

47685

Certificate

3340

Active filter:Authorised representative SRN:FR-AR-000003774

8 device results listed.

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LeukoStrat CDx FLT3 Mutation Assay

LeukoStrat CDx FLT3 Mutation Assay

IVD Class CIVDR 2017/746No longer on the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00810022732557
Basic UDI-DI
081002273K41204314J
Reference
K4120431
EMDN
W01060299
EMDN description
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country
France
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
30.07.2026 19:50
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
IdentiClone® Dx IGH Assay

IdentiClone® Dx IGH Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00810022732502
Basic UDI-DI
08100227391010101P9
Reference
91010101
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
30.07.2026 19:50
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
LeukoStrat CDx FLT3 Mutation Assay

-

IVD Class CNot specifiedOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00810022732595
Basic UDI-DI
081002273K41204314J
Reference
K4120431
EMDN
W01060299
EMDN description
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country
-
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
28.07.2026 12:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
LeukoStrat® NPM1 Mutation Assay Megakit - ABI Fluorescence Detection

NPM1 Mutation Assay for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
D-08100227394160001STX8
Basic UDI-DI
B-08100227394160001STX8
Reference
9-416-0001
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
07.07.2026 23:13
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
T Cell Receptor Gamma Gene Rearrangement

T Cell Receptor Gamma Gene Rearrangement Assay 2.0 Megakit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003630
Basic UDI-DI
B-00850052003630
Reference
9-207-0111
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
T Cell Receptor Gamma Gene Rearrangement

T Cell Receptor Gamma Gene Rearrangement Assay 2.0

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003623
Basic UDI-DI
B-00850052003623
Reference
9-207-0101
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
IGH Gene Clonality Assay

IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003159
Basic UDI-DI
B-00850052003159
Reference
9-101-0081
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
IGH Gene Clonality Assay

IGH Gene Clonality Assay for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Invivoscribe, Inc.
Manufacturer SRN
US-MF-000011736
UDI-DI
00850052003142
Basic UDI-DI
B-00850052003142
Reference
9-101-0061
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Austria
Authorised representative
IN VIVOSCRIBE TECHNOLOGIES
Last updated
05.07.2026 11:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details