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4l DK10AS

by 4L Health Co., Ltd.

Part of a family of 27 devices: see the family page

Ref DK10ASModel DK10 Series

4l DK10AS is a device classified as Class IIb in the EU and Class II in the US made by 4L Health Co., Ltd., registered in EUDAMED on 22 Oct 2022 (Basic UDI-DI 697007637DK10F9) with CE/MDR certificate CN23/00006256 valid until 21 Nov 2028, cleared under FDA 510(k) K190119 on 1 Nov 2019 and listed in FDA GUDID since 15 Jun 2020 (UDI-DI 06970076370113), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

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

510(k) K190119

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberCN23/00006256 Date2 Jul 2024IssuedStatusActive expires 21 Nov 2028
United StatesGUDID listing GUDID Number06970076370113 UDI-DI Date15 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190119 Date1 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697007637DK10F9 registered 22 Oct 2022 Active· +1 more in the status table
  • FDA 510(k) K190119 decided 1 Nov 2019 Active
  • FDA GUDID UDI-DI 06970076370113 listed 15 Jun 2020 Listed

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K190119
  2. Listed FDA GUDID 06970076370113
  3. Registered EUDAMED 697007637DK10F9
  4. Certificate issued EUDAMED CN23/00006256
  5. Certificate expires EUDAMED CN23/00006256

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

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
DK10AS, DK10 Series
Primary DI / UDI-DI
06970076370113
Basic UDI-DI
697007637DK10F9
510(k) Number
FDA product code
OMP
EMDN code
M040499 Dressings for wounds, sores and ulcerations - other
GMDN term
Negative-pressure wound therapy system dressing set
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Romania
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

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Negative-pressure wound therapy system dressing set

Similar devices in this category

Other devices filed under DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER.

Other devices from 4L Health Co., Ltd.

  • Foryou

    Class IIb

  • Foryou NPWT Dressing Kit

    Class II

  • Foryou

    Class IIb

  • Foryou

    Class IIb

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)