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CUSA® Excel C4609S

by Integra Lifesciences (Ireland) Limited

Ref C4609S

CUSA® Excel C4609S is a device classified as Class III (EU), Unclassified (US) made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI B-10381780026006) and listed in FDA GUDID since 27 Jan 2017 (UDI-DI 10381780026006), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780026006 Basic UDI-DI 10381780026006UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780026006 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780026006 registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 10381780026006 listed 27 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780026006
  2. Registered EUDAMED B-10381780026006

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  • Withdrawn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
CUSA® Excel
Generic name
Soft-tissue ultrasonic surgical system handpiece tip, single-use
Device name
CUSA Clarity Ultrasonic Surgical Aspirator System
Model / Ref / Catalog
C4609S
Primary DI / UDI-DI
10381780026006
Basic UDI-DI
B-10381780026006
FDA product code
LFL, LBK
EMDN code
K020299 Devices for surgery with ultrasonic generator, single-use - other
GMDN term
Soft-tissue ultrasonic surgical system handpiece tip, single-use
Device class
Class III EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
U

Device class is stated on each registry's own scale: Class III 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 handpiece tip, single-use

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)