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Lyher

by Hangzhou Laihe Biotech Co., Ltd. China EUDAMED

Ref ISY-402-01Model ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40

EMDN W0105090105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697241261ISY-402MB Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Syphilis Rapid Test
Model / Reference
ISY-402-01, ISY-402-05, ISY-402-20, ISY-402-25, ISY-402-40
Primary DI / UDI-DI
06972412617494
Basic UDI-DI
697241261ISY-402MB
EMDN Code
W0105090105 Syphilis - rt & poc
Device Class
Class C
Market of Registration
Spain

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 (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 8e652eb4-69ad-44d9-b4cf-2ae1e96f0f65 61 fields · synced 24 Oct 2026