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Bistos Co., Ltd.

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

Registration number (SRN)KR-MF-000035951
RoleManufacturer
StatusActive
CountrySouth Korea
City13824 Gyeonggi-do
Address5F and 1502ho, Building D, Gwacheon Pentaone, 117, Gwacheon-daero 12-gil, Gwacheon-si, 13824 Gyeonggi-do
Registered on2023-06-08

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryBistos co., ltd. (KR) · FDA 3006179052

Notified body certificates

No certificate is recorded for this operator in the capture of 2026-08-20. ⚠️ This is not evidence that none exists. Only 3 114 of the 48 893 registered operators carry a certificate in EUDAMED — importers, distributors and authorised representatives never do, and a manufacturer's notified body may simply not have filed one yet.

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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