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VitreQ FC25.D04

by Vitreq B.V.

Ref FC25.D04

VitreQ FC25.D04 is an ophthalmic soft-tissue manipulation forceps (EU MDD Class IIa; FDA Class I; FDA product code HNR, Forceps, Ophthalmic) made by Vitreq B.V., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-08719214220211) and listed in FDA GUDID since 6 Aug 2022 (UDI-DI 08719214220211), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08719214220211 Basic UDI-DI 08719214220211UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719214220211 UDI-DI Date6 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08719214220211 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 08719214220211 listed 6 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719214220211
  2. Registered EUDAMED B-08719214220211

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
VitreQ
Generic name
Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
Model / reference
FC25.D04
Primary DI / UDI-DI
08719214220211 EUDAMED
88719214220217 GUDID
Basic UDI-DI
B-08719214220211
FDA product code
HNR
EMDN code
Q021102 Ophthalmic surgery forceps, single-use
GMDN term
Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4350
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08719214220211
GUDID
88719214220217
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08719214220211; FDA GUDID lists 88719214220217), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Vitreq B.V.

See all devices from Vitreq B.V. →

Properties

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