Skip to content

Visitec® 581019

by Beaver-Visitec International Inc

Ref 581019

Visitec® 581019 is a Class I device made by Beaver-Visitec International Inc, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00886158002253) and listed in FDA GUDID since 27 Jun 2024 (UDI-DI 00886158002253), 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-00886158002253 Basic UDI-DI 00886158002253UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158002253 UDI-DI Date27 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158002253 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158002253 listed 27 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158002253
  2. Registered EUDAMED B-00886158002253

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  • Withdrawn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
Eye patch, single-use
Device name
Ophthalmic Eye Shields
Model / Ref / Catalog
581019
Primary DI / UDI-DI
00886158002253 EUDAMED
30886158002254 GUDID
Basic UDI-DI
B-00886158002253
FDA product code
HOY
EMDN code
M040306 Ophthalmic protectors
GMDN term
Eye patch, single-use
Device class
Class I
Regulation number
886.4750
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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886158002253
GUDID
30886158002254
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00886158002253; FDA GUDID lists 30886158002254), so their flags are not compared.

Related devices

Category: Eye patch

Similar devices in this category

Other devices filed under OPHTHALMIC DRESSINGS.

Other devices from Beaver-Visitec International Inc

See all devices from Beaver-Visitec International Inc →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
Other properties (22, all answered No)