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St Aia-Pack Psaii
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 0025212Ref 0025512
Identity
- Device Name
- ST AIA-PACK PSAII EUDAMEDST AIA-PACK PSAII SAMPLE DILUTING SOLUTION EUDAMED
- Model / Reference
- 0025212 EUDAMED0025512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189210667 EUDAMED04560189211612 EUDAMED
- Basic UDI-DI
- B-14560189210667 EUDAMEDB-04560189211612 EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
St Aia-Pack Psaii by Tosoh Corporation — 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-14560189210667 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 021b0008-7af1-4584-87f9-c18ec7d26efc 61 fields · synced Aug 1, 2026
- EUDAMED 5fe455ba-79d0-49f1-83e0-0b80d3542bb7 61 fields · synced May 19, 2026