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Avance® Solo 882000

by Mölnlycke Health Care AB

Ref 882000

Avance Solo 882000 is a medical device (EU MDR Class IIb; FDA Class II; FDA product code OMP, negative pressure wound therapy Powered suction pump; EMDN category drainage and fluid collection devices) made by Mölnlycke Health Care AB, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 733243000000000343K9), cleared under FDA 510(k) K203369 on 1 Jul 2021 and listed in FDA GUDID since 31 Jan 2022 (UDI-DI 07323190244683), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203369

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number733243000000000343K9 Basic UDI-DI 07323190244683UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07323190244683 UDI-DI Date31 Jan 2022ListedStatusListed 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 733243000000000343K9 registered 16 Oct 2026 Active
  • FDA 510(k) K203369 decided 1 Jul 2021 Active
  • FDA GUDID UDI-DI 07323190244683 listed 31 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203369
  2. Listed FDA GUDID 07323190244683
  3. Registered EUDAMED 733243000000000343K9

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  • Withdrawn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 Foam EUDAMED
Avance® Solo GUDID
Generic name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Model / reference
882000
Primary DI / UDI-DI
07323190244683
Basic UDI-DI
733243000000000343K9
510(k) Number
FDA product code
OMP
EMDN code
A0699 Drainage and fluid collection devices - other
GMDN term
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device class
Class IIb 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 Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 07323190244683: EUDAMED states Yes, FDA GUDID states No.

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 foam dressing, non-antimicrobial

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

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