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CancerCheck® PSA
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref K32-PSAModel 20 tests/kit
Identity
- Trade Name
- CancerCheck® PSA EUDAMED
- Device Name
- PSA Rapid Test EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDK32-PSA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974404980029 EUDAMED
- Basic UDI-DI
- B-06974404980029 EUDAMED
- EMDN Code
- W0102030113 TOTAL 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® PSA 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-06974404980029 | 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 7d2cd876-905f-40ca-9e9b-f626e645d43a 61 fields · synced Jul 9, 2026