Skip to content

Lyher

by Hangzhou Laihe Biotech Co., Ltd. China EUDAMED

Ref IHP-602-07Model IHP-602

EMDN W0105010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697241261IHP-602E3 Basic UDI-DIDate21 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
H.Pylori Antigen Rapid Test
Model / Reference
IHP-602, IHP-602-07
Primary DI / UDI-DI
06972412613564
Basic UDI-DI
697241261IHP-602E3
EMDN Code
W0105010401 H. pylori antigen detection
Device Class
Class B
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 06972412613564|697241261IHP-602E3 61 fields · synced 25 Oct 2026