Manufacturer of medical devices registered in the European database in Hiroishi-cho, Gamagori, Aichi, Japan.
| Registration number (SRN) | JP-MF-000040151 |
|---|---|
| Role | Manufacturer |
| Status | Active |
| Country | Japan |
| City | 443-0038 Hiroishi-cho, Gamagori, Aichi |
| Address | Maehama, 34-14 443-0038 Hiroishi-cho, Gamagori, Aichi |
| Registered on | 2024-02-08 |
| FDA establishment register | Registered with the U.S. FDA |
|---|---|
| Matched entry | NIDEK CO., LTD. (JP) · FDA 8030392 |
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
4202074CE05 | supplemented | expires 2026-11-01 — 17 days | Quality management system | NB 0344 |
4202074CE04 | amended | expires 2026-11-01 — 17 days | Quality management system | NB 0344 |
4202074CE03 | valid | 2028-10-17 | Quality management system | NB 0344 |
4202074CE01 | supplemented | expires 2026-11-01 — 17 days | Quality management system | NB 0344 |
⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.
The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.
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