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Microsponge 8065100002

by Alcon Laboratories, Inc.

Ref 8065100002

Microsponge 8065100002 is a device classified as Class I in the EU and Class II in the US made by Alcon Laboratories, Inc., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 038065GMN000035GW) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00380651000025), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000035GW Basic UDI-DI 00380651000025UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380651000025 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000035GW registered 11 Jun 2026 Active
  • FDA GUDID UDI-DI 00380651000025 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380651000025
  2. Registered EUDAMED 038065GMN000035GW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Microsponge
Generic name
Ophthalmic sponge
Device name
Compressed Cellulose Devices
Model / reference
8065100002
Primary DI / UDI-DI
00380651000025
Basic UDI-DI
038065GMN000035GW
FDA product code
HOZ
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic sponge
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.4790
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 OPHTHALMIC DEVICES - OTHER.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)