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Samyang Biopharm Corporation

South Korea KR-MF-000037085 Last updated 8 Jun 2026

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Devices
110
Registries
EUDAMED
FDA recalls
0

Catalogue110

Page 1 of 3

Showing 1-50 of 110

EUDAMED certificates8

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

EUDAMED certificates (8)

3EC International a.s. 2265 8 certificates

  • 2024-MDR/QS-067/B Amended

    Quality management system EU MDR

    Issued
    5 Jan 2026
    Expires
    12 Dec 2029
    Reason
    Mnf data change
  • 2024-MDR/QS-068/B Supplemented

    Quality management system EU MDR

    Issued
    18 Feb 2026
    Expires
    12 Dec 2029
    Reason
    Add device or group
  • 2024-MDR/QS-069/B Supplemented

    Quality management system EU MDR

    Issued
    25 Feb 2026
    Expires
    12 Dec 2029
    Reason
    Change approved
  • 2024-MDR/TD-067/B Amended

    Technical documentation EU MDR

    Issued
    5 Jan 2026
    Expires
    12 Dec 2029
    Reason
    Mnf data change
  • 2024-MDR/TD-068/B Supplemented

    Technical documentation EU MDR

    Issued
    18 Feb 2026
    Expires
    12 Dec 2029
    Reason
    Add device or group
  • 2024-MDR/TD-069/B Supplemented

    Technical documentation EU MDR

    Issued
    18 Feb 2026
    Expires
    12 Dec 2029
    Reason
    Add device or group
  • 2026-AXVI/TD-003/A Supplemented

    Technical documentation EU MDR

    Issued
    28 Sep 2026
    Expires
    12 Dec 2029
    Reason
    Other
  • 2026-AXVI/QS-003/A Supplemented Expires in 49 days

    Quality management system EU MDR

    Issued
    28 Sep 2026
    Expires
    12 Dec 2026
    Reason
    Other

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Authorised representatives

Notified bodies

Information

Country
South Korea
Address
18beon-gil, 55, munpyeongseo-ro, Daedeok-gu, Daejeon, South Korea
Website
samyang.com
PRRC contact
Ahram Kim
EUDAMED SRN
KR-MF-000037085