← Back to catalogue
Atellica IM Alpha Fetoprotein (AFP)
EUDAMEDClass C (EU MDR)
Ref 10995442Model IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein
Identity
- Trade Name
- Atellica IM Alpha Fetoprotein (AFP) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein EUDAMED10995442 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414597713 EUDAMED
- Basic UDI-DI
- 0405686901798WQ EUDAMED
- Unit of Use DI
- 00630414007267 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Atellica IM Alpha Fetoprotein (AFP) by Siemens Healthcare Diagnostics — 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 | 0405686901798WQ | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- EUDAMED SRN
- US-MF-000016560
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED ccf3be92-ba7d-45ab-bdc6-c7a37a8b89bb 61 fields · synced Jul 26, 2026