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AUTODXTM U-Albumin Test
EUDAMEDClass IVD General (EU MDR)
Ref E1C800Model Dx.UAlbumin
by DxGen Corp.
Identity
- Trade Name
- AUTODXTM U-Albumin Test EUDAMED
- Model / Reference
- Dx.UAlbumin EUDAMEDE1C800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800031900353 EUDAMED
- Basic UDI-DI
- B-08800031900353 EUDAMED
- EMDN Code
- W0102160101 ALBUMIN INCL. UALBUMIN RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
AUTODXTM U-Albumin Test by DxGen Corp. — Class IVD General — 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-08800031900353 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DxGen Corp.
- EUDAMED SRN
- KR-MF-000030876
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 8e8b1d34-3853-41ae-be6d-c3b235fdfece 61 fields · synced Jul 24, 2026