Identity
- Trade Name
- XL CDKN2A/9q22 EUDAMEDXL CDKN2A EUDAMED
- Device Name
- XL CDKN2A/9q22 EUDAMEDXL CDKN2A EUDAMED
- Model / Reference
- D-5118-100-OG EUDAMEDD-5053-100-OG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251315812543 EUDAMED04251315812109 EUDAMED
- Basic UDI-DI
- 42513158D-5118IVDKC EUDAMED42513158D-5053IVDK8 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
XL CDKN2A/9q22 by Metasystems Probes Gmbh — 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 | 42513158D-5118IVDKC | Class C | Active |
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Manufacturer
- Manufacturer
- MetaSystems Probes GmbH
- EUDAMED SRN
- DE-MF-000006315
Sources (2)
- EUDAMED faaba356-c2b4-4a06-9fc9-95d736a4ca73 61 fields · synced Jul 29, 2026
- EUDAMED 9f7f3c67-c9ef-40f8-a682-d881cf3de42a 61 fields · synced May 18, 2026