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Aution Max (ax-4030)
EUDAMEDClass IVD General (EU MDR)
Ref 102674Ref 14506Ref 14504
Identity
- Trade Name
- AUTION MAX (AX-4030) EUDAMED
- Device Name
- AUTION MAX (AX-4030) EUDAMED
- Model / Reference
- 102674 EUDAMED14506 EUDAMED14504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-102674MD EUDAMEDD-14506FS EUDAMEDD-14504FN EUDAMED
- Basic UDI-DI
- B-102674MD EUDAMEDB-14506FS EUDAMEDB-14504FN EUDAMED
- EMDN Code
- W020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDRomania EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Aution Max (ax-4030) by ARKRAY Factory, Inc. — 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-102674MD | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (3)
- EUDAMED 0ba0694c-ada2-473a-94b3-3cb7acb55ef5 61 fields · synced Jul 20, 2026
- EUDAMED c8653e8b-a9ab-429b-8b23-e729b1ba7474 61 fields · synced May 18, 2026
- EUDAMED fd6e6690-92a7-4a9c-8781-d411833e3e82 61 fields · synced Jul 20, 2026