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ADVIA Centaur Free PSA Calibrator (fPSA Cal)
EUDAMEDClass C (EU MDR)
Ref 10361919Model IVDR_67_TTN_DUB-C_C_REAG_Free PSA Calibrator
Identity
- Trade Name
- ADVIA Centaur Free PSA Calibrator (fPSA Cal) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_C_REAG_Free PSA Calibrator EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_C_REAG_Free PSA Calibrator EUDAMED10361919 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414557748 EUDAMED
- Basic UDI-DI
- 0405686901852W5 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
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
ADVIA Centaur Free PSA Calibrator (fPSA Cal) 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 | 0405686901852W5 | 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 3e999e14-a164-48fc-82a5-969d10fefd5a 61 fields · synced Jul 15, 2026