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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Optical Coherence Tomography RS-1

UDI-DI 04987669203705Basic UDI-DI 4987669216GF

Class IIa · MDR · NIDEK.CO.Ltd.,

Identification
Model
RS-1,Mirante,RS-3000 Advance
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
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/optical-coherence-tomography-rs-1-3705 · UDI page: /udi/04987669203705

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