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EUDAMED update: Dec 9, 2025
JP-MF-000040151JP-MF-000040151SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →NIDEK.CO.Ltd., is a medical device manufacturer registered in EUDAMED. The company has 5 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Hiroishi-cho, Gamagori, Aichi, Japan. Explore the regulatory profile, devices and certificates on MD Atlas.
Devices placed in 32 countries
1 approved member
Showing 1–5 of 5 devices.
| Product | Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|---|
| Eye Care Data Management Platform EyeLink | Eye Care Data Management Platform EyeLink | EP001-0040 | 04987669204764 | 1 | On the market |
| Fully Assisted Refraction System FARS | Fully Assisted Refraction System FARS | RTP15-0A40 | 04987669203552 | 1 | On the market |
| Non-Mydriatic Auto Fundus Camera AFC-1 | Non-Mydriatic Auto Fundus Camera AFC-1 | FC013-0040 | 04987669204528 | 1 | On the market |
| Open-field Refraction System PHANTOM | Open-field Refraction System PHANTOM | PH001-0040 | 04987669204610 | 1 | On the market |
| Optical Coherence Tomography RSD-1 | Optical Coherence Tomography RSD-1 | SA006-0040 | 04987669204542 | 1 | On the market |
15 EU importers place this manufacturer's devices
1 authorised representative routes this manufacturer's devices
Certificate 4202074CE04Rev. 5Manufacturer
NIDEK.CO.Ltd.
Notified body
DEKRA Certification B.V.
Version
1
Valid from
10/30/2025
Valid until
11/1/2026
Certificate 4202074CE03Rev. 0Manufacturer
NIDEK.CO.Ltd.
Notified body
DEKRA Certification B.V.
Version
1
Valid from
10/17/2023
Valid until
10/17/2028
Certificate 4202074CE05Rev. 1Manufacturer
NIDEK.CO.Ltd.
Notified body
DEKRA Certification B.V.
Version
1
Valid from
1/23/2026
Valid until
11/1/2026
Showing 1–3 of 3 device families.