GE HANGWEI MEDICAL SYSTEMS CO., LTD.

SRN

CN-MF-000009292

Role

Manufacturer

Country

China

Organization name

GE HANGWEI MEDICAL SYSTEMS CO., LTD.

EU VAT number

Not applicable

Trade register

911103026000081377

Date of registration

Jul 7, 2021

Email

eudamed@gehealthcare.com

Address

WEST AREA OF BUILDING NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA 100176 BEIJING CHINA

Name

Agence Nationale de Sécurité du Médicament et des Produits de Santé

SRN

FR-CA-008

Phone

+ 33 (1) 5587 3000

Email

contact.eudamed@ansm.sante.fr

• SUN Ying
  a. the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; b. the post-market surveillance obligations are complied with in accordance with EU MDR Article 10(10); c. the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled;
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• WANG Xing
  a. the technical documentation and the EU declaration of conformity are drawn up and kept up to date; b. investigational devices conform to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
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