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Free Prostate Specific Antigen (FPSA) (Light-initiated Chemiluminescence Immuno…
EUDAMEDClass C (EU MDR)
Ref 12010108822 Model 2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests
Identity
- Device Name
- Free Prostate Specific Antigen (FPSA) (Light-initiated Chemiluminescence Immunoassay, LiCA) EUDAMED
- Model / Reference
- 2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests EUDAMED12010108822 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864381797 EUDAMED
- Basic UDI-DI
- 6973864380084F4 EUDAMED
- Direct Marketing DI
- 06973864381797 EUDAMED
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Czechia 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
Free Prostate Specific Antigen (FPSA) (Light-initiated Chemiluminescence Immuno… by Chemclin Diagnostics Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 6973864380084F4 | Class C | Active |
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Manufacturer
- Manufacturer
- Chemclin Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000009729
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 5d513f5b-0c63-4515-8aca-fbe47e4dc54d 61 fields · synced Jun 18, 2026