Skip to content

Integra® CEV8104IU

by Integra Microfrance

Ref CEV8104IU

Integra® CEV8104IU is a device classified as Class I in the EU and Class II in the US made by Integra Microfrance, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-10381780428862) and listed in FDA GUDID since 4 Apr 2019 (UDI-DI 10381780428862), 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-10381780428862 Basic UDI-DI 10381780428862UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780428862 UDI-DI Date4 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780428862 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 10381780428862 listed 4 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780428862
  2. Registered EUDAMED B-10381780428862

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  • Withdrawn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® EUDAMED
Integra® GUDID
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Device name
Insert
Model / Ref / Catalog
CEV8104IU
Primary DI / UDI-DI
10381780428862
Basic UDI-DI
B-10381780428862
FDA product code
GCJ
EMDN code
L03130401 Tissue and organ grasping forceps, reusable
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
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 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: Rigid endoscopic tissue manipulation forceps, reusable

Similar devices in this category

Other devices filed under TISSUE AND ORGAN GRASPING FORCEPS, REUSABLE.

Other devices from Integra Microfrance

See all devices from Integra Microfrance →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)