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Biosynex

by Hangzhou Laihe Biotech Co., Ltd. China EUDAMED

Ref 860618

EMDN W010106020301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972412612628 Basic UDI-DIDate28 Aug 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
Uritop +2
Model / Reference
860618
Primary DI / UDI-DI
06972412612628
Basic UDI-DI
B-06972412612628
EMDN Code
W010106020301 Urine sediment test kit (manual)
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000033566
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Hangzhou Laihe Biotech Co., Ltd.

See all devices from Hangzhou Laihe Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06972412612628|B-06972412612628 61 fields · synced 25 Oct 2026