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Manufacturer of medical devices registered in the European database in Deogyang-gu, Goyang-si, Gyeonggi-do, South Korea.
| Registration number (SRN) | KR-MF-000009035 |
|---|---|
| Short name | LUTRONIC |
| Role | Manufacturer |
| Status | Active |
| Country | South Korea |
| City | 10534 Deogyang-gu, Goyang-si, Gyeonggi-do |
| Address | SOWON-RO, 219 10534 Deogyang-gu, Goyang-si, Gyeonggi-do |
| Registered on | 2021-07-01 |
| FDA establishment register | Registered with the U.S. FDA |
|---|---|
| Matched entry | LUTRONIC CORPORATION (KR) · FDA 3004483538 |
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
C555614 | cancelled | 2029-07-04 | Quality management system | NB 2460 |
2975-MED-2601901 | valid | 2031-01-18 | Quality management system | NB 2975 |
⚠️ 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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