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FIZE Disposable- Pediatrics, 10EA

by FIZE Medical Ltd. EUDAMED

Active European Union

Ref FI-FG00-KU03-0004Model FIZE kUO Disposable Kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0729001923KIT3B Basic UDI-DIDate12 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
FIZE kUO Disposable Kit
Model / Reference
FIZE kUO Disposable Kit, FI-FG00-KU03-0004
Primary DI / UDI-DI
17290019239205
Basic UDI-DI
0729001923KIT3B
EMDN Code
A06030301 Urine collection bags
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IL-MF-000046483
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from FIZE 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