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Sterile Alginate Wound Dressing

by Qingdao Bright Moon Biomedical Material Co., Ltd. China EUDAMED

Ref AF07Model Non-adhesive Dressing,Self-adhesive Dressing

EMDN M04040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN24/00001294 Date5 Mar 2024IssuedStatusActive expires 5 Mar 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN24/00001294 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    5 Mar 2024
    Expires
    5 Mar 2029

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Non-adhesive Dressing, Self-adhesive Dressing, AF07
Primary DI / UDI-DI
06934889081604
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 071dc273-0a39-46bb-83d3-3a83bb60e2eb 61 fields · synced 22 Oct 2026