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PSA Qualitative Rapid Test Cassette
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref TPS-Q402
Identity
- Trade Name
- PSA Qualitative Rapid Test Cassette EUDAMED
- Device Name
- PSA Qualitative Rapid Test Cassette EUDAMED
- Model / Reference
- TPS-Q402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983100960 EUDAMED06936983120074 EUDAMED
- Basic UDI-DI
- B-06936983100960 EUDAMEDB-06936983120074 EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
PSA Qualitative 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-06936983100960 | 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 (2)
- EUDAMED 71eca950-d40b-4959-a95b-d8fae471f3b6 61 fields · synced Jul 30, 2026
- EUDAMED ebda8151-5afc-4381-b559-e7c4e934b09f 61 fields · synced May 17, 2026