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LabStrip U12 mALB/CREA

by 77 Elektronika Műszeripari Kft Hungary EUDAMED

Ref U12-9901-1 EMDN W0101060205

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05997345781198 Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Urine test strip - LabStrip U12 mALB/CREA
Model / Reference
U12-9901-1
Primary DI / UDI-DI
05997345781198
Basic UDI-DI
B-05997345781198
EMDN Code
W0101060205 Urine multi-constituent test strips (automated)
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000004266

Other devices from 77 Elektronika Műszeripari Kft

See all devices from 77 Elektronika Műszeripari Kft →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b0c10f53-7020-4368-bd21-7a4e74f5a583 61 fields · synced 22 Oct 2026