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tPSA CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0305Model AutoLumo analyzerRef CMB0303Ref CMB0302
Identity
- Trade Name
- tPSA CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0305 EUDAMEDCMB0303 EUDAMEDCMB0302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359548410 EUDAMED06942359548397 EUDAMED06970150908294 EUDAMED
- Basic UDI-DI
- 697015090000111GS EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
Yes
EUDAMEDEUDAMED
tPSA CLIA Microparticles by Autobio Diagnostics 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 | 697015090000111GS | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 33758dc4-90f3-4d14-aaf5-d18ebd1a6125 61 fields · synced Jul 25, 2026
- EUDAMED 00db006b-aca4-49fe-a950-0c28e7a67257 61 fields · synced May 18, 2026
- EUDAMED 39ec2235-719c-459e-83a5-bd5749ac5c24 61 fields · synced May 19, 2026