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Foryou

by 4L Health Co., Ltd 3 variants

Ref DK10SSModel DK10 Series, DK10SS,DK10MS,DK10LS,DK10XS,DK10AS,DK10SD,DK10MD,DK10LD,DK10XD,DK10AD

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

21 Nov 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberCN23/00006256 Date2 Jul 2024IssuedStatusActive expires 21 Nov 2028
European UnionCE/MDD EUDAMED Number697007637DK10F9 Basic UDI-DI 06970076370076UDI-DIDate22 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06970076370076 UDI-DI Date15 Jun 2020ListedStatusListed GUDID: in commercial distribution

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Foryou EUDAMED
4l GUDID
Generic Name
Negative-pressure wound therapy system dressing set
Device Name
NPWT Dressing Kit
Model / Reference
DK10 Series, DK10SS, DK10MS, DK10LS, DK10XS, DK10AS, DK10SD, DK10MD, DK10LD, DK10XD, DK10AD
Primary DI / UDI-DI
06970076370076
Basic UDI-DI
697007637DK10F9, B-06970076370076
510(k) Number
FDA Product Code
OMP
EMDN Code
M040499, A0699
GMDN Term
Negative-pressure wound therapy system dressing set
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4780
EU market of registration
Romania
Slovakia
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Related devices

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

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
  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No