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Aution Eleven (ae-4020)
EUDAMEDClass IVD General (EU MDR)
Ref 102676Ref 14405Ref 14440Ref 107309Ref 107310Ref 107308
Identity
- Trade Name
- AUTION ELEVEN (AE-4020) EUDAMED
- Device Name
- AUTION ELEVEN (AE-4020) EUDAMED
- Model / Reference
- 102676 EUDAMED14405 EUDAMED14440 EUDAMED107309 EUDAMED107310 EUDAMED107308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-102676MH EUDAMEDD-14405FK EUDAMEDD-14440FM EUDAMED04987486033141 EUDAMED04987486033158 EUDAMED04987486033134 EUDAMED
- Basic UDI-DI
- B-102676MH EUDAMEDB-14405FK EUDAMEDB-14440FM EUDAMED4987486BC0107308GN EUDAMED
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Romania EUDAMEDCzechia EUDAMEDItaly EUDAMEDIreland 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
New Device
No
EUDAMED
Aution Eleven (ae-4020) by ARKRAY Factory, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-102676MH | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-102676MH | 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 (6)
- EUDAMED 41e996bc-b9b4-4787-ab98-b3d834acbc00 61 fields · synced Aug 2, 2026
- EUDAMED fe8c4e87-22be-4375-8126-7beefc3fc1c4 61 fields · synced May 18, 2026
- EUDAMED 50422be7-eb88-4c3c-b6cd-e2aeca13cb3d 61 fields · synced May 18, 2026
- EUDAMED 880fd5fd-33f8-4ac9-ae07-a0e350d0697f 61 fields · synced May 18, 2026
- EUDAMED b03aaa0c-2289-40c4-9659-eb25857bd075 61 fields · synced May 18, 2026
- EUDAMED 21f9f349-526d-4bd6-8133-398d6dcaf046 61 fields · synced May 19, 2026