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MicroFrance® MCL78

by Integra Microfrance

Ref MCL78

MicroFrance® MCL78 is a device classified as Class IIa in the EU and Class I in the US made by Integra Microfrance, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-10381780106135) and listed in FDA GUDID since 10 Jan 2018 (UDI-DI 10381780106135), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780106135 Basic UDI-DI 10381780106135UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780106135 UDI-DI Date10 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780106135 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 10381780106135 listed 10 Jan 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780106135
  2. Registered EUDAMED B-10381780106135

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  • Withdrawn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
MicroFrance®
Generic name
ENT transilluminator
Model / Ref / Catalog
MCL78
Primary DI / UDI-DI
10381780106135
Basic UDI-DI
B-10381780106135
FDA product code
CCW
EMDN code
Q0399 ENT devices - other
GMDN term
ENT transilluminator
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5540
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: ENT transilluminator

Similar devices in this category

Other devices filed under ENT DEVICES - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)