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Integra® 00MLX

by Integra Lifesciences (Ireland) Limited

Ref 00MLX

Integra® 00MLX is a device classified as Class I in the EU and Class II in the US made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 038178B0038CSS3T) and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 10381780168140), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0038CSS3T Basic UDI-DI 10381780168140UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780168140 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038178B0038CSS3T registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 10381780168140 listed 7 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780168140
  2. Registered EUDAMED 038178B0038CSS3T

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  • Withdrawn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
Integra®
Generic name
General-purpose light source
Device name
MLX Light Source
Model / Ref / Catalog
00MLX
Primary DI / UDI-DI
10381780168140
Basic UDI-DI
038178B0038CSS3T
Direct marketing DI
10381780168140
FDA product code
FCW
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
General-purpose light source
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
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: General-purpose light source

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Integra Lifesciences (Ireland) Limited

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)