Identity
- Trade Name
- IdentiClone® Dx IGH Assay EUDAMED
- Device Name
- IdentiClone® Dx IGH Assay EUDAMED
- Model / Reference
- 91010101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810022732502 EUDAMED
- Basic UDI-DI
- 08100227391010101P9 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
IdentiClone® Dx IGH Assay by Invivoscribe, Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08100227391010101P9 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invivoscribe, Inc.
- EUDAMED SRN
- US-MF-000011736
- Authorised Representative
- IN VIVOSCRIBE TECHNOLOGIES FR-AR-000003774
Sources (1)
- EUDAMED 30114845-8652-438e-99c4-d75bf94b0213 61 fields · synced Jun 18, 2026