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Xtra Sequestration Set X

by Sorin Group Italia SRL

Ref 04315

Xtra Sequestration Set X is a blood donor set (EU MDR Class IIb; FDA Class II) made by Sorin Group Italia SRL, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 8033178CARDATSSEQSL), cleared under FDA 510(k) K241236 on 16 Aug 2024 and listed in FDA GUDID since 20 Dec 2024 (UDI-DI 08033178114332), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241236

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8033178CARDATSSEQSL Basic UDI-DI 08033178114332UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033178114332 UDI-DI Date20 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK241236 Date16 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8033178CARDATSSEQSL registered 23 Jul 2026 Active
  • FDA 510(k) K241236 decided 16 Aug 2024 Active
  • FDA GUDID UDI-DI 08033178114332 listed 20 Dec 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241236
  2. Listed FDA GUDID 08033178114332
  3. Registered EUDAMED 8033178CARDATSSEQSL

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  • Withdrawn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
Generic name
Blood donor set, double-pack
Device name
Autotransfusion
Model / reference
04315 EUDAMED
SEQUESTRATION SET X GUDID
Primary DI / UDI-DI
08033178114332
Basic UDI-DI
8033178CARDATSSEQSL
510(k) Number
FDA product code
CAC, DTN
EMDN code
B0480 Autotransfusion devices - accessories
GMDN term
Blood donor set, double-pack
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5830, 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
04315
GUDID
SEQUESTRATION SET X
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: Blood donor set, double-pack

Cleared under the same submission (K241236)

and 8 more cleared under K241236

Similar devices in this category

Other devices filed under AUTOTRANSFUSION DEVICES.

Other devices from Sorin Group Italia SRL

See all devices from Sorin Group Italia SRL →

Properties

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