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Vivadiag

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

Ref LA-137-2Model LC-101

EMDN W0101050202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975519631448 Basic UDI-DIDate5 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Lipid Testing System Control Solution
Model / Reference
LC-101, LA-137-2
Primary DI / UDI-DI
06975519631448
Basic UDI-DI
B-06975519631448
EMDN Code
W0101050202 Lipid controls
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 37c2d7fd-7519-459f-82ce-e87ecf9ed606 61 fields · synced 22 Oct 2026