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Mepiform

by Mölnlycke Health Care AB 3 variants

Ref 293401

Mepiform (293401) is a device classified as Class IIa in the EU and Class I in the US made by Mölnlycke Health Care AB, registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI 733243000000000463KL) and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 07333350600297), active as of 9 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07333350600297 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number733243000000000463KL Basic UDI-DI 07333350600297UDI-DIDate4 Sep 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 733243000000000463KL registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 07333350600297 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 733243000000000463KL
  2. Listed FDA GUDID 07333350600297

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Scar-management dressing, single-use
Device name
Mepiform Sterile
Model / reference
293401
Primary DI / UDI-DI
07333350600297
Basic UDI-DI
733243000000000463KL
FDA product code
MDA
EMDN code
M04040701 Silicone dressings, non-combined
GMDN term
Scar-management dressing, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4025
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
SE-MF-000014042

Similar devices in this category

Other devices filed under SILICONE DRESSINGS, NON-COMBINED.

Other devices from Mölnlycke Health Care AB

See all devices from Mölnlycke Health Care AB →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)