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CUSA® Clarity C7000

by Integra Lifesciences (Ireland) Limited

Ref C7000

CUSA® Clarity C7000 is a device classified as Class IIb (EU), Unclassified (US) made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 038178B0199CSS6H) and listed in FDA GUDID since 23 Nov 2016 (UDI-DI 10381780126232), 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 Number038178B0199CSS6H Basic UDI-DI 10381780126232UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780126232 UDI-DI Date23 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038178B0199CSS6H registered 10 Jul 2026 Active
  • FDA GUDID UDI-DI 10381780126232 listed 23 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780126232
  2. Registered EUDAMED 038178B0199CSS6H

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  • Withdrawn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® Clarity
Generic name
Soft-tissue ultrasonic surgical system
Model / Ref / Catalog
C7000
Primary DI / UDI-DI
10381780126232
Basic UDI-DI
038178B0199CSS6H
FDA product code
LFL, LBK
EMDN code
Z12010880 Instruments for ultrasonic surgery - hardware accessories
GMDN term
Soft-tissue ultrasonic surgical system
Device class
Class IIb EUDAMED
U GUDID
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 IIb
GUDID
U

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Soft-tissue ultrasonic surgical system

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES.

Other devices from Integra Lifesciences (Ireland) Limited

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)