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Visitec® 581069

by Beaver-Visitec International Inc

Ref 581069

Visitec® 581069 is a device classified as Class IIa in the EU and Class II in the US made by Beaver-Visitec International Inc, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00886158002390) and listed in FDA GUDID since 27 Jun 2024 (UDI-DI 00886158002390), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00886158002390 Basic UDI-DI 00886158002390UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158002390 UDI-DI Date27 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158002390 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158002390 listed 27 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158002390
  2. Registered EUDAMED B-00886158002390

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  • Withdrawn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
Visitec®
Generic name
Ophthalmic sponge
Device name
Ophthalmic Fluid Control
Model / Ref / Catalog
581069
Primary DI / UDI-DI
00886158002390 EUDAMED
30886158002391 GUDID
Basic UDI-DI
B-00886158002390
FDA product code
HOZ
EMDN code
A06030499 Intra-operation fluid collection devices - other
GMDN term
Ophthalmic sponge
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.4790
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886158002390
GUDID
30886158002391
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Related devices

Category: Ophthalmic sponge

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Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
Other properties (23, all answered No)