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VitreQ CN23.D03

by Vitreq B.V.

Ref CN23.D03

VitreQ CN23.D03 is a device classified as Class IIa in the EU and Class I in the US made by Vitreq B.V., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-08719214221423) and listed in FDA GUDID since 5 Sep 2022 (UDI-DI 08719214221423), 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-08719214221423 Basic UDI-DI 08719214221423UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719214221423 UDI-DI Date5 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08719214221423 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 08719214221423 listed 5 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719214221423
  2. Registered EUDAMED B-08719214221423

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  • Withdrawn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 laser system beam guide
Model / reference
CN23.D03
Primary DI / UDI-DI
08719214221423 EUDAMED
88719214221429 GUDID
Basic UDI-DI
B-08719214221423
FDA product code
HMX
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic laser system beam guide
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
08719214221423
GUDID
88719214221429
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08719214221423; FDA GUDID lists 88719214221429), 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 laser system beam guide

Similar devices in this category

Other devices filed under OPHTHALMIC 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)