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fPSA CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0505Model AutoLumo analyzerRef CMB0503
Identity
- Trade Name
- fPSA CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0505 EUDAMEDCMB0503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359548519 EUDAMED06942359548496 EUDAMED
- Basic UDI-DI
- 697015090000112GU EUDAMED
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
fPSA CLIA Microparticles by Autobio Diagnostics Co., Ltd. — 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 | 697015090000112GU | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED ff68e37b-8a99-48e6-8696-3c7c3cf27fa4 61 fields · synced Jul 26, 2026
- EUDAMED 35cda6a8-f464-4819-9a5b-16098ff5aa4b 61 fields · synced May 18, 2026