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Urine Strip

by Hivis Medical Technology Co., Ltd China EUDAMED

Ref V-1

EMDN W020101020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978100260003 Basic UDI-DIDate4 Feb 2025RegisteredStatusActive

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 22 Oct 2026

Device Name
Urine Strip
Model / Reference
V-1
Primary DI / UDI-DI
06978100260003
Basic UDI-DI
B-06978100260003
EMDN Code
W020101020101 Urine strip readers
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046009
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Hivis Medical Technology Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 117b2fa7-2bda-4c7f-a23b-a162f1667ada 61 fields · synced 22 Oct 2026