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Mefix® 312000

by Mölnlycke Health Care AB

Ref 312000

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number733243000000000012JF Basic UDI-DI 07333350207571UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07333350207571 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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

Trade Name
Mefix EUDAMED
Mefix® GUDID
Generic Name
Dressing-fixation skin adhesive tape, non-silicone
Model / Reference
312000
Primary DI / UDI-DI
07333350207571
Basic UDI-DI
733243000000000012JF
FDA Product Code
KGX
EMDN Code
M04010201 Non-woven fixing dressings
GMDN Term
Dressing-fixation skin adhesive tape, non-silicone
Device Class
Class I
Regulation Number
880.5240
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Other devices from Mölnlycke Health Care AB

See all devices from Mölnlycke Health Care AB →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No