Skip to content

Xres Holder

by Sorin Group Italia SRL

Ref 04272

Xres Holder is a medical device service rail clamp (EU MDR Class I; FDA Class II; FDA product code DTN, Reservoir, blood, cardiopulmonary bypass) made by Sorin Group Italia SRL, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 8033178BRAXTRAWH), cleared under FDA 510(k) K100507 on 24 Mar 2010 and listed in FDA GUDID since 24 Oct 2023 (UDI-DI 08033178110846), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100507

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8033178BRAXTRAWH Basic UDI-DI 08033178110846UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033178110846 UDI-DI Date24 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK100507 Date24 Mar 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8033178BRAXTRAWH registered 23 Jul 2026 Active
  • FDA 510(k) K100507 decided 24 Mar 2010 Active
  • FDA GUDID UDI-DI 08033178110846 listed 24 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K100507
  2. Listed FDA GUDID 08033178110846
  3. Registered EUDAMED 8033178BRAXTRAWH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Xtra EUDAMED
Xres GUDID
Generic name
Medical device service rail clamp
Device name
Brackets
Model / reference
04272 EUDAMED
HOLDER GUDID
Primary DI / UDI-DI
08033178110846
Basic UDI-DI
8033178BRAXTRAWH
510(k) Number
FDA product code
DTN
EMDN code
C030180 Extracorporeal and assisted circulation devices - accessories
GMDN term
Medical device service rail clamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.4400
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
04272
GUDID
HOLDER
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Medical device service rail clamp

Cleared under the same submission (K100507)

Similar devices in this category

Other devices filed under EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - ACCESSORIES.

Other devices from Sorin Group Italia SRL

See all devices from Sorin Group Italia SRL →

Properties

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