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Sterile Alginate Wound Dressing

by Qingdao Bright Moon Biomedical Material Co., Ltd. 32 variants

Ref AD80Model Non-adhesive Dressing,Self-adhesive Dressing

Active European Union

CE MDR

Valid until

5 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN24/00001294 Date5 Mar 2024IssuedStatusActive EUDAMED: not on the EU market expires 5 Mar 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN24/00001294 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    5 Mar 2024
    Expires
    5 Mar 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Non-adhesive Dressing, Self-adhesive Dressing, AD80
Primary DI / UDI-DI
06934889081444
Basic UDI-DI
69348890SAWD01YL
EMDN Code
M04040201 Alginate dressings, non-combined
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000021492
Authorised representative
Prolinx GmbH DE-AR-000005129

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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