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Avance® 890003

by Mölnlycke Health Care AB

Ref 890003

Avance® 890003 is a device classified as Class I in the EU and Class II in the US made by Mölnlycke Health Care AB, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 733243000000000330JY), cleared under FDA 510(k) K203369 on 1 Jul 2021 and listed in FDA GUDID since 31 Oct 2024 (UDI-DI 07333350965044), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K203369

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 Number733243000000000330JY Basic UDI-DI 07333350965044UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07333350965044 UDI-DI Date31 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK203369 Date1 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 733243000000000330JY registered 24 Sep 2026 Active
  • FDA 510(k) K203369 decided 1 Jul 2021 Active
  • FDA GUDID UDI-DI 07333350965044 listed 31 Oct 2024 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K203369
  2. Listed FDA GUDID 07333350965044
  3. Registered EUDAMED 733243000000000330JY

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  • Withdrawn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
Avance Solo Carrier Case EUDAMED
Avance® GUDID
Generic name
Negative-pressure wound therapy system, electric, single-use
Model / reference
890003
Primary DI / UDI-DI
07333350965044
Basic UDI-DI
733243000000000330JY
510(k) Number
FDA product code
OMP
EMDN code
A0699 Drainage and fluid collection devices - other
GMDN term
Negative-pressure wound therapy system, electric, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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, electric, single-use

Cleared under the same submission (K203369)

and 8 more cleared under K203369

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - OTHER.

Other devices from Mölnlycke Health Care AB

See all devices from Mölnlycke Health Care AB →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)