Skip to content

Monarch® 8065977762

by Alcon Laboratories, Inc.

Ref 8065977762

Monarch® 8065977762 is a device classified as Class IIa in the EU and Class I in the US made by Alcon Laboratories, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380659777622) and listed in FDA GUDID since 20 May 2020 (UDI-DI 00380659777622), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00380659777622 Basic UDI-DI 00380659777622UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380659777622 UDI-DI Date20 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380659777622 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380659777622 listed 20 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380659777622
  2. Registered EUDAMED B-00380659777622

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  • Withdrawn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
Monarch EUDAMED
Monarch® GUDID
Generic name
Intraocular lens-insertion cartridge
Device name
Monarch II/III Cartridge
Model / reference
8065977762
Primary DI / UDI-DI
00380659777622
Basic UDI-DI
B-00380659777622
FDA product code
MSS
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Intraocular lens-insertion cartridge
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4300
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Intraocular lens-insertion cartridge

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
  • Serial number
  • Expiration date
Other properties (19, all answered No)