Autobio Biochemistry Co.,Ltd

SRN

SRN

An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.

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CN-MF-000038143

Role

Manufacturer

Country

China

Organization name

Autobio Biochemistry Co.,Ltd

EU VAT number

Not applicable

Date of registration

Oct 12, 2023

Email

ra@autobio-bj.com.cn

Address

BUILDING 17 &18, NO.13 COURTYARD, MINTAI ROAD, BEIWU TOWN, SHUNYI DISTRICT, BEIJING. 101399 BEIJING CHINA

Name

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

SRN

SRN

An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.

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BE-CA-007

Phone

+32 2 528 40 00

Email

notifications.meddev@fagg-afmps.be

• LI Yan
  1.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; 2. the post-market surveillance process complies with the IVDR; the post-market surveillance obligations are complied with in accordance with Article 10(9); 3.the reporting obligations referred to in Articles 82 to 86 are fulfilled;
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• LIU Chunlong
  1.The TD and the EU DOC are drawn up and kept up-to-date. 2.Products' performance evalution involving special risks meets the requirements; For devices conducting clinical performance studies, the statement referred to in Section 4.1 of Annex XIV is issued and signed. 3.Assist in ensuring that the PMS process complies with IVDR; the PMS obligations are complied with in accordance with Article 10(9). 4.the reporting obligations referred to in Articles 82 to 86 are fulfilled with assistance.
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