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AP224

by Eitan Medical Ltd

Ref 12004-000-0005Model AVOSET; SAPPHIRE

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290109150002WR Basic UDI-DI 17290109154876UDI-DIDate3 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  • Withdrawn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
Administration Sets
Model / Reference
AVOSET, SAPPHIRE, 12004-000-0005
Primary DI / UDI-DI
17290109154876
Basic UDI-DI
7290109150002WR
EMDN Code
Z12030385 Infusion instruments - consumables
Device Class
Class IIa
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
IL-MF-000011869
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from Eitan Medical Ltd

See all devices from Eitan Medical Ltd →

Properties

  • Sterile

Other properties (12)

  • 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