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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

AUTO REF/KERATOMETER ARK-1e

UDI-DI 04987669100745Basic UDI-DI 4987669202G4

Class IIa · MDR · NIDEK.CO.Ltd.,

Identification
Model
ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

4202074CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-06-30 · Expiry 2026-11-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

NIDEK.CO.Ltd.,

SRN JP-MF-000040151

JP · Hiroishi-cho, Gamagori, Aichi

manufacturer

Authorised representative: NIDEK SA (FR-AR-000000341)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/auto-ref-keratometer-ark-1e-0745 · UDI page: /udi/04987669100745

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