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Fabco Q604007

by First Aid Bandage Co Inc

Ref Q604007

Fabco Q604007 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 21 Sep 2026 (Basic UDI-DI 0634303IVALONORINGME) and listed in FDA GUDID since 1 Nov 2016 (UDI-DI 30634303800213), 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 Number0634303IVALONORINGME Basic UDI-DI 30634303800213UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30634303800213 UDI-DI Date1 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0634303IVALONORINGME registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 30634303800213 listed 1 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 30634303800213
  2. Registered EUDAMED 0634303IVALONORINGME

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  • Withdrawn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
Model / Ref / Catalog
Q604007
Primary DI / UDI-DI
30634303800213
Basic UDI-DI
0634303IVALONORINGME
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
Lumen/Inner Diameter — 14.2 Millimeter
Outer Diameter — 18.3 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)