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CUSA® Excel CV260438000

by Integra Lifesciences (Ireland) Limited

Ref CV260438000

CUSA® Excel CV260438000 is a device classified as Class I (EU), Unclassified (US) made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 038178B0034CSS2X) and listed in FDA GUDID since 29 Dec 2016 (UDI-DI 10381780039532), active as of 24 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0034CSS2X Basic UDI-DI 10381780039532UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780039532 UDI-DI Date29 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038178B0034CSS2X registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 10381780039532 listed 29 Dec 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 10381780039532
  2. Registered EUDAMED 038178B0034CSS2X

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  • Withdrawn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
Generic name
Surgical suction system collection container, single-use
Device name
Ultrasonic Surgical Aspirator System
Model / Ref / Catalog
CV260438000
Primary DI / UDI-DI
10381780039532
Basic UDI-DI
038178B0034CSS2X
FDA product code
LFL, LBK
EMDN code
A0680 Drainage and fluid collection devices - accessories
GMDN term
Surgical suction system collection container, single-use
Device class
Class I EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
U

Device class is stated on each registry's own scale: Class I 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: Surgical suction system collection container, single-use

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)