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CancerCheck ® fPSA
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref K32-FPSAModel 20 tests/kit
Identity
- Trade Name
- CancerCheck ® fPSA EUDAMED
- Device Name
- fPSA Rapid Test EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDK32-FPSA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974404980036 EUDAMED
- Basic UDI-DI
- B-06974404980036 EUDAMED
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
CancerCheck ® fPSA by Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974404980036 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024153
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED c71095c7-062b-419b-a465-49a1ea751f4f 61 fields · synced Oct 6, 2026