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6431233B

by Gambro Dasco SpA

Ref 101354

6431233B (101354) is a device classified as Class IIa in the EU and Class II in the US made by Gambro Dasco SpA, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI 7332414VA0000753E) and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 07332414004699), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7332414VA0000753E Basic UDI-DI 07332414004699UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07332414004699 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7332414VA0000753E registered 29 Jul 2026 Active
  • FDA GUDID UDI-DI 07332414004699 listed 28 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07332414004699
  2. Registered EUDAMED 7332414VA0000753E

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  • Withdrawn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
S-660-C Accessory "Y" Connector
Generic name
Haemodialysis blood tubing set, single-use
Model / Ref / Catalog
101354, 6431233B
Primary DI / UDI-DI
07332414004699
Basic UDI-DI
7332414VA0000753E
FDA product code
FJK
EMDN code
F020180 Arteriovenous dialysis lines for haemodialysis - haemofiltration -haemodiafiltration - accessories
GMDN term
Haemodialysis blood tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5820
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
101354
GUDID
6431233B
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Haemodialysis blood tubing set, single-use

Similar devices in this category

Other devices filed under ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION.

Other devices from Gambro Dasco SpA

See all devices from Gambro Dasco SpA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)