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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Image Filing Software NAVIS-EX

UDI-DI 04987669101643Basic UDI-DI 4987669217GH

Class IIa · MDR · NIDEK.CO.Ltd.,

Identification
Model
NAVIS-EX
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

4202074CE05

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/image-filing-software-navis-ex-1643 · UDI page: /udi/04987669101643

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