Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

HANDHELD REF/KERATOMETER HandyRef-K

UDI-DI 04987669100769Basic UDI-DI 4987669202G4

Class IIa · MDR · NIDEK.CO.Ltd.,

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Identification

Model: ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K
EMDN: Q0299, Z12120113
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

SRN JP-MF-000040151

JP · Hiroishi-cho, Gamagori, Aichi

manufacturer

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

Related UDI-DIs

AUTO REF/KERATOMETER ARK-1 04987669100714
AUTO REF/KERATOMETER ARK-1a 04987669100721
AUTO REF/KERATOMETER ARK-1e 04987669100745
AUTO REF/KERATOMETER ARK-1s 04987669100738
AUTO REF/KERATOMETER ARK-F 04987669101476

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/handheld-ref-keratometer-handyref-k-0769 · UDI page: /udi/04987669100769

All devices from NIDEK.CO.Ltd.,

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