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VitreQ SQ00.D01

by Vitreq B.V.

Ref SQ00.D01

VitreQ SQ00.D01 is a medical device (EU MDD Class I; FDA Class I; FDA product code HMX, Cannula, Ophthalmic; EMDN category vitrectomy devices) made by Vitreq B.V., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-08719214222659) and listed in FDA GUDID since 5 Sep 2022 (UDI-DI 08719214222659), 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-08719214222659 Basic UDI-DI 08719214222659UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719214222659 UDI-DI Date5 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08719214222659 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 08719214222659 listed 5 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719214222659
  2. Registered EUDAMED B-08719214222659

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  • Withdrawn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 surgical irrigation/infusion/aspiration handle, single-use
Model / reference
SQ00.D01
Primary DI / UDI-DI
08719214222659 EUDAMED
88719214222655 GUDID
Basic UDI-DI
B-08719214222659
FDA product code
HMX
EMDN code
Q020499 Vitrectomy devices - other
GMDN term
Ophthalmic surgical irrigation/infusion/aspiration handle, single-use
Device class
Class I
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 · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08719214222659
GUDID
88719214222655

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08719214222659; FDA GUDID lists 88719214222655), so their flags are not compared.

Related devices

Category: Ophthalmic surgical irrigation/infusion/aspiration handle, single-use

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)