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SD Biosensor Inc.

Manufacturer of medical devices registered in the European database in Gyeonggi-do, Suwon-si, South Korea.

Registration number (SRN)KR-MF-000009168
Short nameSD Biosensor
RoleManufacturer
StatusActive
CountrySouth Korea
City16690 Gyeonggi-do, Suwon-si
AddressDeogyeong-daero, 1556beon-gil 16690 Gyeonggi-do, Suwon-si
Registered on2021-07-05

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entrySD BIOSENSOR, INC. (KR) · FDA 3012133212

Notified body certificates

CertificateStatusExpiryTypeBody
V76 075369 0076valid2031-07-14Technical documentationNB 0123
V76 075369 0075valid2031-06-24Technical documentationNB 0123
V76 075369 0071valid2030-07-08Technical documentationNB 0123
V74 075369 0070restricted2030-04-07Technical documentationNB 0123
V13 075369 0072supplemented2030-03-16Quality management systemNB 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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