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Oneness Biotech Co., Ltd

Manufacturer of medical devices registered in the European database in Taipei City, Taiwan.

Registration number (SRN)TW-MF-000032480
RoleManufacturer
StatusActive
CountryTaiwan
City100 Taipei City
Address35F, No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist.,, 100 Taipei City
Registered on2023-01-06

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryOneness Biotech Co., Ltd. (TW) · FDA 3015077448

Notified body certificates

CertificateStatusExpiryTypeBody
ECM26MDR002valid2031-03-08Quality management systemNB 1282

⚠️ 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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