Identity
- Trade Name
- AUTION EYE Sheath Solution EUDAMED
- Device Name
- AUTION EYE Sheath Solution EUDAMED
- Model / Reference
- 108526 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486040170 EUDAMED
- Basic UDI-DI
- 4987486BC0107664HF EUDAMED
- EMDN Code
- W01010902 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
New Device
No
EUDAMED
AUTION EYE Sheath Solution by ARKRAY Factory, Inc. — Class A — 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 | 4987486BC0107664HF | Class A | 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 (1)
- EUDAMED c964d953-ddac-480d-a125-f8b060737531 61 fields · synced Jun 19, 2026