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Fabco Q605204

by First Aid Bandage Co Inc

Ref Q605204

Fabco Q605204 is an ear wick (EU MDR Class I; FDA Class I; FDA product code KCN, Ear Wick) made by First Aid Bandage Co Inc, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 0634303IVALONEARPOSTOPWK) and listed in FDA GUDID since 5 Mar 2018 (UDI-DI 30634303800404), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0634303IVALONEARPOSTOPWK Basic UDI-DI 30634303800404UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30634303800404 UDI-DI Date5 Mar 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0634303IVALONEARPOSTOPWK registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 30634303800404 listed 5 Mar 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 30634303800404
  2. Registered EUDAMED 0634303IVALONEARPOSTOPWK

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  • Withdrawn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
Fabco Ivalon EUDAMED
Fabco GUDID
Generic name
Ear wick, non-biodegradable
Device name
Ear Packing
Model / Ref / Catalog
Q605204
Primary DI / UDI-DI
30634303800404
Basic UDI-DI
0634303IVALONEARPOSTOPWK
FDA product code
KCN
EMDN code
M0406 Dressings for the prevention of post-operative adhesions
GMDN term
Ear wick, non-biodegradable
Device class
Class I
Regulation number
874.5220
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Height — 24 Millimeter
Outer Diameter — 12 Millimeter

Related devices

Category: Ear wick, non-biodegradable

Similar devices in this category

Other devices filed under DRESSINGS FOR THE PREVENTION OF POST-OPERATIVE ADHESIONS.

Other devices from First Aid Bandage Co Inc

See all devices from First Aid Bandage Co Inc →

Properties

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