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Lyher

by Hangzhou Laihe Biotech Co., Ltd. China EUDAMED

Ref 303034701-01Model 303034701-01;303034701-05;303034701-20;303034701-25;303034701-40

EMDN W0105090699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0697241261IRS-552BJ Basic UDI-DIDate3 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Respiratory multiple 5 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno)
Model / Reference
303034701-01, 303034701-05, 303034701-20, 303034701-25, 303034701-40
Primary DI / UDI-DI
06972412617937
Basic UDI-DI
0697241261IRS-552BJ
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class B
Market of Registration
Spain

Manufacturer details

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

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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 06972412617937|0697241261IRS-552BJ 61 fields · synced 25 Oct 2026