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Visiwipe 581047

by Beaver-Visitec International Inc

Ref 581047

Visiwipe 581047 is an ophthalmic sponge (EU MDD Class I; FDA Class I; FDA product code MDM, Instrument, Manual, Surgical, General Use) made by Beaver-Visitec International Inc, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00886158002321) and listed in FDA GUDID since 10 Sep 2025 (UDI-DI 00886158002321), 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-00886158002321 Basic UDI-DI 00886158002321UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158002321 UDI-DI Date10 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158002321 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158002321 listed 10 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158002321
  2. Registered EUDAMED B-00886158002321

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  • Withdrawn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
Visiwipe
Generic name
Ophthalmic sponge
Device name
OPHTHALMIC INSTRUMENT WIPES-CLASS Is
Model / Ref / Catalog
581047
Primary DI / UDI-DI
00886158002321
Basic UDI-DI
B-00886158002321
FDA product code
MDM
EMDN code
V0799 Products for cleaning medical devices not included in other classes - other
GMDN term
Ophthalmic sponge
Device class
Class I
Regulation number
878.4800
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 · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00886158002321: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Ophthalmic sponge

Similar devices in this category

Other devices filed under PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Beaver-Visitec International Inc

See all devices from Beaver-Visitec International Inc →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)