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EUDAMED Device Search

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

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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: 16.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View 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: 16.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details

LeukoStrat CDx FLT3 Mutation Assay

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IVD Class CIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagent

Manufacturer: Invivoscribe, Inc.
Manufacturer SRN: US-MF-000011736
UDI-DI: 00810022732595
Basic UDI-DI: 081002273K41204314J
Reference: -
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: -
Authorised representative: IN VIVOSCRIBE TECHNOLOGIES
Last updated: 05.06.2026 16:15

Manufacturer products Authorised representative products Authorised representative actors View details