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Freevent Dressing Softfoam L 8034

by Atos Medical AB

Ref 8034

Freevent Dressing Softfoam L 8034 is a Class I device made by Atos Medical AB, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 7331791-COM-0-0G0-0002-J7) and listed in FDA GUDID since 24 Oct 2025 (UDI-DI 07331791014086), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7331791-COM-0-0G0-0002-J7 Basic UDI-DI 07331791014086UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07331791014086 UDI-DI Date24 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7331791-COM-0-0G0-0002-J7 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 07331791014086 listed 24 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07331791014086
  2. Registered EUDAMED 7331791-COM-0-0G0-0002-J7

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  • Withdrawn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
Freevent Dressing Softfoam L
Generic name
Tracheostomy tube dressing
Device name
Freevent Dressing Softfoam
Model / Ref / Catalog
8034
Primary DI / UDI-DI
07331791014086
Basic UDI-DI
7331791-COM-0-0G0-0002-J7
Unit of use DI
07331791181283
FDA product code
NAD
EMDN code
M0499 Special dressings - other
GMDN term
Tracheostomy tube dressing
Device class
Class I
Regulation number
878.4020
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under SPECIAL DRESSINGS - OTHER.

Other devices from Atos Medical AB

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Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)