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Foryou

by 4L Health Co., Ltd China EUDAMED

Ref DK10MS-AModel DK10 Series

EMDN M040499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697007637DK10F9 Basic UDI-DIDate22 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN23/00006256 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    2 Jul 2024
    Expires
    21 Nov 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Device Name
NPWT Dressing Kit
Model / Reference
DK10 Series, DK10MS-A
Primary DI / UDI-DI
06970076370564
Basic UDI-DI
697007637DK10F9
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class IIb
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000017929
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from 4L Health Co., Ltd.

See all devices from 4L Health Co., Ltd. →

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 06970076370564|697007637DK10F9 61 fields · synced 24 Oct 2026