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Detection Kit for Hepatitis E Virus IgM Antibody (ELISA)

by Zhongshan Bio-Tech Co., Ltd. EUDAMED

Active European Union

Ref WG0101-96Model 96 tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936791010062 Basic UDI-DIDate17 Oct 2022RegisteredStatusActive

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  • Withdrawn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
Detection Kit for Hepatitis E Virus IgM Antibody (ELISA)
Model / Reference
96 tests/kit, WG0101-96
Primary DI / UDI-DI
06936791010062
Basic UDI-DI
B-06936791010062
EMDN Code
W0105020505 Hev antibody igm
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028828
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No