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SurgiGuard

by Samyang Biopharm Corporation

Ref DMHO201

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2024-MDR/QS-069/B Date25 Feb 2026IssuedStatusWithdrawn No longer placed on the EU market expires 12 Dec 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2024-MDR/QS-069/B Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    25 Feb 2026
    Expires
    12 Dec 2029
    Reason
    Change approved
  • 2024-MDR/TD-069/B Active Supplemented

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    18 Feb 2026
    Expires
    12 Dec 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Absorbable hemostat
Model / Reference
DMHO201
Primary DI / UDI-DI
08806227005420
Basic UDI-DI
88062270SG01PP
EMDN Code
M040501 Polysaccharide haemostatic dressings
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000037085
Authorised representative
Samyang Biopharm Magyarország Kft. HU-AR-000035346

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No