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AUTION EYE Sheath Solution

EUDAMED

Class A (EU MDR)

Ref 107665Ref 108524Ref 107664Ref 108525Ref 108522

by ARKRAY Factory, Inc.

Identity

Trade Name
AUTION EYE Sheath Solution EUDAMED
Device Name
AUTION EYE Sheath Solution EUDAMED
Model / Reference
107665 EUDAMED
108524 EUDAMED
107664 EUDAMED
108525 EUDAMED
108522 EUDAMED

Identifiers

Primary DI / UDI-DI
04987486035992 EUDAMED
04987486040156 EUDAMED
04987486035985 EUDAMED
04987486040163 EUDAMED
04987486040132 EUDAMED
Basic UDI-DI
4987486BC0107664HF EUDAMED
EMDN Code
W01010902 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Ireland EUDAMED
Romania EUDAMED
Poland EUDAMED
Portugal 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

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Manufacturer

Manufacturer
ARKRAY Factory, Inc.
EUDAMED SRN
JP-MF-000003008
Authorised Representative
ARKRAY Europe, B.V. NL-AR-000002056

Sources (5)

  • EUDAMED dc3216ba-99b9-49cd-b7e3-19aa2215d2ee 61 fields · synced Jul 29, 2026
  • EUDAMED 02913d9e-53a5-4575-ae0e-fc80adbd119f 61 fields · synced May 16, 2026
  • EUDAMED 47dd7465-52f3-4eda-a392-e7f3101d2478 61 fields · synced May 17, 2026
  • EUDAMED aa3f6301-874e-4722-85fa-644f51528dfb 61 fields · synced May 18, 2026
  • EUDAMED d764a912-5721-4c9b-9684-89b6da2684de 61 fields · synced May 18, 2026