Skip to content

COVID-19 Neutralizing Antibody Test Kit

by Hangzhou Laihe Biotech Co., Ltd. EUDAMED

Active European Union

Ref 303057; 303058

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972412612703 Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
COVID-19 Neutralizing Antibody Test Kit
Model / Reference
303057, 303058
Primary DI / UDI-DI
06972412612703
Basic UDI-DI
B-06972412612703
EMDN Code
W0105090502 Coronavirus antibody (ab) - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000033566
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Laihe Biotech Co., Ltd.

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

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No