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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-24 · Link to EUDAMED

EyeCee ONE preloaded

UDI-DI 04987669316030Basic UDI-DI 4987669227GL

Class IIb · MDR · NIDEK.CO.Ltd.,

Identification
Model
NP-1
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

4202074CE04

EU quality management system · unknown

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

Valid from 2025-10-30 · Expiry 2026-11-01

Scope not stated in certificate data.

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

4202074TD01

EU technical documentation assessment · unknown

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

Valid from 2025-10-30 · Expiry 2028-12-13

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

Showing 12 of 235 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/eyecee-one-preloaded-6030 · UDI page: /udi/04987669316030

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