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MicroFrance® CP821E

by Integra Microfrance

Ref CP821E

MicroFrance CP821E 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-10381780100447) and listed in FDA GUDID since 2 Jun 2017 (UDI-DI 10381780100447), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780100447 Basic UDI-DI 10381780100447UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780100447 UDI-DI Date2 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780100447 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 10381780100447 listed 2 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780100447
  2. Registered EUDAMED B-10381780100447

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  • Withdrawn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
CP821E
Primary DI / UDI-DI
10381780100447
Basic UDI-DI
B-10381780100447
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

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - OTHER.

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)