Skip to content

LabStrip U11 Plus

by 77 Elektronika Műszeripari Kft Hungary EUDAMED

Ref ANA-9901-1

EMDN W0101060204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05997345777979 Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Urine test strip - LabStrip U11 Plus
Model / Reference
ANA-9901-1
Primary DI / UDI-DI
05997345777979
Basic UDI-DI
B-05997345777979
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
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
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 05997345777979|B-05997345777979 61 fields · synced 25 Oct 2026