Identity
- Trade Name
- OncoMate® 5C Matrix Standard EUDAMED
- Device Name
- OncoMate® 5C Matrix Standard EUDAMED
- Model / Reference
- MD3850 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849811057137 EUDAMED
- Basic UDI-DI
- B-00849811057137 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
OncoMate® 5C Matrix Standard by Promega Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00849811057137 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Promega Corporation
- EUDAMED SRN
- US-MF-000034520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 1b19129a-5c22-49fe-88dd-abe1ce3de576 61 fields · synced Jun 19, 2026