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Weck-Cel 0008685

by Beaver-Visitec International Inc

Ref 0008685

Weck-Cel 0008685 is an ophthalmic sponge (EU MDD Class IIa; FDA Class II; FDA product code HOZ, Sponge, ophthalmic) made by Beaver-Visitec International Inc, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-30886158010846) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 30886158010846), 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-30886158010846 Basic UDI-DI 30886158010846UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30886158010846 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30886158010846 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 30886158010846 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 30886158010846
  2. Registered EUDAMED B-30886158010846

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  • Withdrawn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
Weck-Cel
Generic name
Ophthalmic sponge
Device name
Ophthalmic Fluid Control
Model / reference
0008685
Primary DI / UDI-DI
30886158010846
Basic UDI-DI
B-30886158010846
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
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 30886158010846: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic sponge

Similar devices in this category

Other devices filed under INTRA-OPERATION FLUID COLLECTION DEVICES - 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
  • Expiration date
Other properties (18, all answered No)