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Kids D130 40µm Neonatal Arterial Filter

by Sorin Group Italia SRL

Ref 050583

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8033178FILTERMDRKIDSUH Basic UDI-DI 08033178112857UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033178112857 UDI-DI Date31 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Kids D130 EUDAMED
Kids GUDID
Generic Name
Cardiopulmonary bypass system filter, arterial blood line
Device Name
Filters
Model / Reference
050583 EUDAMED
D130 40µm Neonatal Arterial Filter GUDID
Primary DI / UDI-DI
08033178112857
Basic UDI-DI
8033178FILTERMDRKIDSUH
510(k) Number
FDA Product Code
DTM
EMDN Code
C03010104 Extracorporeal circulation filters
GMDN Term
Cardiopulmonary bypass system filter, arterial blood line
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4260
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
050583
GUDID
D130 40µm Neonatal Arterial Filter
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K242953)

Other devices from Sorin Group Italia SRL

See all devices from Sorin Group Italia SRL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No