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Non-DEHP Admin Set with Non-Vented Spike and 1.2μ Filter, Check Valve

by Zevex Inc.

Ref 380-4128-VModel 380-4128

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081484400816912D7 Basic UDI-DI 10814844001201UDI-DIDate4 Aug 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Non-DEHP Admin Set with Non-Vented Spike and 1.2μ Filter
Model / Reference
380-4128, 380-4128-V
Primary DI / UDI-DI
10814844001201
Basic UDI-DI
081484400816912D7
EMDN Code
Z12030385 Infusion instruments - consumables
Device Class
Class IIa
EU market of registration
Lithuania

Manufacturer details

EUDAMED SRN
US-MF-000005937
Authorised representative
UAB Moog Vilnius LT-AR-000017784

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Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No