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Fabco Q604250

by First Aid Bandage Co Inc

Ref Q604250

Fabco Q604250 is a device classified as Class I in the EU and Class II in the US made by First Aid Bandage Co Inc, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 0634303IVALONEYESPEARQS) and listed in FDA GUDID since 1 Nov 2016 (UDI-DI 30634303800343), 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 Number0634303IVALONEYESPEARQS Basic UDI-DI 30634303800343UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30634303800343 UDI-DI Date1 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0634303IVALONEYESPEARQS registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 30634303800343 listed 1 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 30634303800343
  2. Registered EUDAMED 0634303IVALONEYESPEARQS

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  • Withdrawn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
Ophthalmic sponge
Device name
Surgical Eye Spear
Model / Ref / Catalog
Q604250
Primary DI / UDI-DI
30634303800343
Basic UDI-DI
0634303IVALONEYESPEARQS
FDA product code
HOZ
EMDN code
Q021113 Ophthalmic surgery instrument kits, single-use
GMDN term
Ophthalmic sponge
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.4790
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Height — 10 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Ophthalmic sponge

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE.

Other devices from First Aid Bandage Co Inc

See all devices from First Aid Bandage Co Inc →

Properties

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