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GenSure Biotech Inc.

China CN-MF-000028354 Last updated 21 Oct 2026

Devices
82
Registries
EUDAMED
FDA recalls
0

Catalogue82

Page 1 of 2

Showing 1-50 of 82

EUDAMED certificates7

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (7)

TÜV SÜD Product Service GmbH 0123 5 certificates

  • V13 126886 0002 Issued

    Quality management system EU IVDR

    Issued
    16 Jul 2025
    Expires
    15 Jul 2030
  • V76 126886 0003 Issued

    Technical documentation EU IVDR

    Issued
    16 Jul 2025
    Expires
    15 Jul 2030
  • V76 126886 0004 Issued

    Technical documentation EU IVDR

    Issued
    16 Jul 2025
    Expires
    15 Jul 2030
  • V76 126886 0006 Issued

    Technical documentation EU IVDR

    Issued
    14 Jul 2025
    Expires
    13 Jul 2030
  • V76 126886 0005 Issued

    Technical documentation EU IVDR

    Issued
    11 Jul 2025
    Expires
    10 Jul 2030

Notified body 0344 2 certificates

  • 6211186CE01 Issued

    Quality management system EU IVDR

    Issued
    20 Jan 2026
    Expires
    1 Jan 2031
  • 6211186TD01 Issued

    Technical documentation EU IVDR

    Issued
    20 Jan 2026
    Expires
    1 Jan 2031

Authorised representatives

Notified bodies

About

It's a major research and development project in Hebei province

Translated from the manufacturer's own website. Source

Information

Country
China(from SRN)
Address
5F, No. 5, Lane 396, Luzhouhuan Rd., Minhang District, 201114 Shanghai, China., Shanghai, China
Phone
400 007 9938(from company website)
PRRC contact
Shaodan Zhang
EUDAMED SRN
CN-MF-000028354