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DiaRapid PSA Rapid Test Cassette
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref SPS-402
Identity
- Trade Name
- DiaRapid PSA Rapid Test Cassette EUDAMED
- Device Name
- DiaRapid PSA Rapid Test Cassette EUDAMED
- Model / Reference
- SPS-402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942598212509 EUDAMED
- Basic UDI-DI
- B-06942598212509 EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
DiaRapid PSA Rapid Test Cassette by Hangzhou Alltest Biotech.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-06942598212509 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 253bbd5e-3318-4df9-8f4f-e4914ab1e9ca 61 fields · synced Jun 19, 2026