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Integra® ICP-22

by Integra Lifesciences (Ireland) Limited

Part of a family of 24 devices: see the family page

Ref ICP-22

Integra® ICP-22 is a device classified as Class I in the EU and Class II in the US made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 038178B0036CSS3D) and listed in FDA GUDID since 29 Dec 2016 (UDI-DI 10381780039716), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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/MDR EUDAMED Number038178B0036CSS3D Basic UDI-DI 10381780039716UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780039716 UDI-DI Date29 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038178B0036CSS3D registered 8 Jul 2026 Active
  • FDA GUDID UDI-DI 10381780039716 listed 29 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780039716
  2. Registered EUDAMED 038178B0036CSS3D

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
CUSA® Excel EUDAMED
Integra® GUDID
Generic name
Electrical-only medical device connection cable, reusable
Device name
lntegra Monitor cables
Model / Ref / Catalog
ICP-22
Primary DI / UDI-DI
10381780039716
Basic UDI-DI
038178B0036CSS3D
Direct marketing DI
10381780039716
FDA product code
GWM
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1620
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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: Electrical-only medical device connection cable, reusable

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)