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MicroFrance® CP821C

by Integra Microfrance

Ref CP821C

MicroFrance CP821C is a surgical instrument handle (EU MDD Class I; FDA Class I; FDA product code GDZ, Handle, Scalpel) made by Integra Microfrance, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-10381780100423) and listed in FDA GUDID since 29 Sep 2017 (UDI-DI 10381780100423), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780100423 Basic UDI-DI 10381780100423UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780100423 UDI-DI Date29 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780100423 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 10381780100423 listed 29 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780100423
  2. Registered EUDAMED B-10381780100423

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  • Withdrawn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
Surgical instrument handle, non-torque-limiting
Device name
Instrument holder
Model / Ref / Catalog
CP821C
Primary DI / UDI-DI
10381780100423
Basic UDI-DI
B-10381780100423
FDA product code
GDZ
EMDN code
L149099, L99
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
878.4800
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

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Other devices filed under ENT INSTRUMENTS, REUSABLE - 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)