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VitreQ BF00.D53

by Vitreq B.V.

Ref BF00.D53

VitreQ BF00.D53 is a vitrectomy fluid/gas handling handpiece/cannula (EU MDD Class IIa; FDA Class I; FDA product code HMX, Cannula, Ophthalmic) made by Vitreq B.V., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-08719214221065) and listed in FDA GUDID since 5 Sep 2022 (UDI-DI 08719214221065), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08719214221065 Basic UDI-DI 08719214221065UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719214221065 UDI-DI Date5 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08719214221065 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 08719214221065 listed 5 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719214221065
  2. Registered EUDAMED B-08719214221065

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  • Withdrawn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
Vitrectomy fluid/gas handling handpiece/cannula
Model / reference
BF00.D53
Primary DI / UDI-DI
08719214221065 EUDAMED
88719214221061 GUDID
Basic UDI-DI
B-08719214221065
FDA product code
HMX
EMDN code
Q020499 Vitrectomy devices - other
GMDN term
Vitrectomy fluid/gas handling handpiece/cannula
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
08719214221065
GUDID
88719214221061
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08719214221065; FDA GUDID lists 88719214221061), 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: Vitrectomy fluid/gas handling handpiece/cannula

Similar devices in this category

Other devices filed under VITRECTOMY DEVICES - OTHER.

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)