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Ningbo Xinwell Medical Technology Co., Ltd

Manufacturer of medical devices registered in the European database in Cixi, Zhejiang, China.

Registration number (SRN)CN-MF-000001084
Short nameXinwell
RoleManufacturer
StatusActive
CountryChina
City315301 Cixi, Zhejiang
AddressNo.188 Binjiang Road,Cixi High-tech Industrial Development Zone, 315301 Cixi, Zhejiang
Registered on2021-02-02

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryNINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. (CN) · FDA 3017178358

Notified body certificates

CertificateStatusExpiryTypeBody
HZ 2114114-1supplementedexpired 2026-09-29Quality management systemNB 0197

⚠️ 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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