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Bausch + Lomb CX9400

by Bausch & Lomb Incorporated

Ref CX9400

Bausch + Lomb CX9400 is a device classified as Class IIb in the EU and Class II in the US made by Bausch & Lomb Incorporated, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 0310119B1027ZJ) and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00757770454044), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0310119B1027ZJ Basic UDI-DI 00757770454044UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00757770454044 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0310119B1027ZJ registered 20 Aug 2026 Active
  • FDA GUDID UDI-DI 00757770454044 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00757770454044
  2. Registered EUDAMED 0310119B1027ZJ

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  • Withdrawn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
Bausch + Lomb Bipolar Cable EUDAMED
Bausch + Lomb GUDID
Generic name
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Device name
Stellaris Handpieces
Model / Ref / Catalog
CX9400
Primary DI / UDI-DI
00757770454044
Basic UDI-DI
0310119B1027ZJ
Direct marketing DI
00757770454044
FDA product code
GEI
EMDN code
Q020680 Phacoemulsification devices - accessories
GMDN term
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Similar devices in this category

Other devices filed under PHACOEMULSIFICATION DEVICES.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
Other properties (22, all answered No)