Home › South Korea › i-SENS, Inc.
Manufacturer of medical devices registered in the European database in Seoul, South Korea.
| Registration number (SRN) | KR-MF-000009173 |
|---|---|
| Role | Manufacturer |
| Status | Active |
| Country | South Korea |
| City | 06646 Seoul |
| Address | Banpo-daero 28-gil, Seocho-gu, 43 06646 Seoul |
| Registered on | 2021-07-05 |
| FDA establishment register | Registered with the U.S. FDA |
|---|---|
| Matched entry | I-SENS, INC. (KR) · FDA 3005621222 |
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
V76 090700 0062 | supplemented | 2029-01-29 | Technical documentation | NB 0123 |
V13 090700 0058 | supplemented | 2028-11-28 | Quality management system | NB 0123 |
G10 090700 0039 | supplemented | 2029-02-27 | Quality management system | NB 0123 |
⚠️ 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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