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MicroFrance® MCL206

by Integra Microfrance

Ref MCL206

MicroFrance® MCL206 is a Class I device made by Integra Microfrance, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-10381780105220) and listed in FDA GUDID since 10 Jan 2018 (UDI-DI 10381780105220), 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-10381780105220 Basic UDI-DI 10381780105220UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780105220 UDI-DI Date10 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780105220 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 10381780105220 listed 10 Jan 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780105220
  2. Registered EUDAMED B-10381780105220

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  • Withdrawn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
Mouth gag, adjustable, reusable
Device name
Mouth gag
Model / Ref / Catalog
MCL206
Primary DI / UDI-DI
10381780105220
Basic UDI-DI
B-10381780105220
FDA product code
KBN
EMDN code
L14010205, L150202
GMDN term
Mouth gag, adjustable, reusable
Device class
Class I
Regulation number
874.4420
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

Related devices

Category: Mouth gag, adjustable, reusable

Similar devices in this category

Other devices filed under L14010205.

Other devices from Integra Microfrance

See all devices from Integra Microfrance →

Properties

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