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ADVIA Centaur Tumor Marker Quality Control (TM QC)
EUDAMEDClass C (EU MDR)
Ref 11538186Model IVDR_67_TTN_DUB-C_C_REAG_TM QC
Identity
- Trade Name
- ADVIA Centaur Tumor Marker Quality Control (TM QC) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_C_REAG_TM QC EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_C_REAG_TM QC EUDAMED11538186 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414608273 EUDAMED
- Basic UDI-DI
- 0405686902362VN EUDAMED
- Unit of Use DI
- 00630414306063 EUDAMED
- EMDN Code
- W0102152205 TUMOUR MARKER STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
ADVIA Centaur Tumor Marker Quality Control (TM QC) 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 | 0405686902362VN | Class C | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- EUDAMED SRN
- US-MF-000016560
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED ffd9d218-2fa2-4fa0-87df-2cb7ce9d5fcc 61 fields · synced Jul 9, 2026