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Unity 00380650004185

by Alcon Laboratories, Inc.

Ref 8065000418

Unity 00380650004185 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 13 Jul 2026 (Basic UDI-DI 038065GMN000190HB) and listed in FDA GUDID since 8 Apr 2025 (UDI-DI 00380650004185), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000190HB Basic UDI-DI 00380650004185UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380650004185 UDI-DI Date8 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000190HB registered 13 Jul 2026 Active
  • FDA GUDID UDI-DI 00380650004185 listed 8 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380650004185
  2. Registered EUDAMED 038065GMN000190HB

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  • Withdrawn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
Unity
Generic name
Medical equipment/instrument drape, single-use
Device name
Tray Arm Cover
Model / Ref / Catalog
8065000418, 00380650004185
Primary DI / UDI-DI
00380650004185
Basic UDI-DI
038065GMN000190HB
FDA product code
HMT
EMDN code
T030199 Covers, instruments and equipment - other
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8065000418
GUDID
00380650004185
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: Medical equipment/instrument drape, single-use

Similar devices in this category

Other devices filed under COVERS, INSTRUMENTS AND EQUIPMENT - 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)