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Aution Max (ax-4060)
EUDAMEDClass IVD General (EU MDR)
Ref 100525Ref 105885Ref 100528
Identity
- Trade Name
- AUTION MAX (AX-4060) EUDAMED
- Device Name
- AUTION MAX (AX-4060) EUDAMED
- Model / Reference
- 100525 EUDAMED105885 EUDAMED100528 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100525LD EUDAMEDD-105885NH EUDAMEDD-100528LK EUDAMED
- Basic UDI-DI
- B-100525LD EUDAMEDB-105885NH EUDAMEDB-100528LK EUDAMED
- EMDN Code
- W020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMEDPoland 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-4060) 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-100525LD | 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 7124389c-4caa-418a-a319-5e6daf7ea309 61 fields · synced Jul 16, 2026
- EUDAMED b7f1f94a-b9a1-4c02-b7b1-96b30ecaf305 61 fields · synced Jul 8, 2026
- EUDAMED 39bc10e5-17cb-41cc-98e0-04697308ce96 61 fields · synced Jul 10, 2026