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Foryou

by 4L Health Co., Ltd 23 variants

Ref DK10XD-SModel DK10 Series

Active European Union

CE MDR

Valid until

21 Nov 2028

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN23/00006256 Date2 Jul 2024IssuedStatusActive expires 21 Nov 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN23/00006256 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    2 Jul 2024
    Expires
    21 Nov 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
NPWT Dressing Kit
Model / Reference
DK10 Series, DK10XD-S
Primary DI / UDI-DI
06970076370557
Basic UDI-DI
697007637DK10F9
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class IIb
EU 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.

  • Foryou

    Class IIb

  • 4l DK10AS

    Class II

  • Foryou NPWT Dressing Kit

    Class II

  • Foryou

    Class IIb

  • Foryou

    Class IIb

  • Foryou

    Class IIb

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

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