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Prostate- Specific Antigen (PSA) Rapid Test
EUDAMEDClass C (EU MDR)
Ref TPS-NQ402HE-02B
Identity
- Trade Name
- Prostate- Specific Antigen (PSA) Rapid Test EUDAMED
- Device Name
- Prostate- Specific Antigen (PSA) Rapid Test EUDAMED
- Model / Reference
- TPS-NQ402HE-02B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942598231494 EUDAMED
- Basic UDI-DI
- 6970277510015EY7 EUDAMED
- EMDN Code
- W0102160202 PSA - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prostate- Specific Antigen (PSA) Rapid Test by Hangzhou Alltest Biotech.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 | 6970277510015EY7 | Class C | 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 2603439b-150e-4e7f-abcf-20b4045d3403 61 fields · synced Jun 19, 2026