Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

Max 30

UDI-DI 00038214001742Basic UDI-DI 00038214NIDEK4L

Class IIb · MDR · Nidek Medical Products Inc.

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Identification

Model: —
EMDN: Z12159004
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

28620155820-00-01

EU quality management system · unknown

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-09-01 · Expiry 2027-12-13

Scope not stated in certificate data.

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

Manufacturer

Nidek Medical Products Inc.

SRN US-MF-000007253

US · Birmingham

manufacturer

Authorised representative: mdi Europa GmbH (DE-AR-000006218)

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Mark 5 Nuvo Lite 00038214000066
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Showing 12 of 14 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/max-30-1742 · UDI page: /udi/00038214001742

All devices from Nidek Medical Products Inc.

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