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Legionella Pneumophila Rapid Test

by VivaChek Biotech (Hangzhou) Co., Ltd. China EUDAMED

Ref VILEG-101 EMDN W0105090108

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-VILEG-101HD Basic UDI-DIDate14 Nov 2025RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
VILEG-101
Primary DI / UDI-DI
D-VILEG-101HD
Basic UDI-DI
B-VILEG-101HD
EMDN Code
W0105090108 Legionella - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from VivaChek Biotech (Hangzhou) Co., Ltd.

See all devices from VivaChek Biotech (Hangzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 7a5ff6b0-e66f-41fc-9b14-315b37b0cf66 61 fields · synced 25 Oct 2026