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Sample Reagent

by Ustar Biotechnologies (Hangzhou) Ltd. China EUDAMED

Ref U400091-20

EMDN W05019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697349224U4000910A000HR Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sample Reagent
Model / Reference
U400091-20
Primary DI / UDI-DI
06973492243726
Basic UDI-DI
697349224U4000910A000HR
Direct Marketing DI
06973492243726
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000014615
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ustar Biotechnologies (Hangzhou) Ltd.

See all devices from Ustar Biotechnologies (Hangzhou) Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06973492243726|697349224U4000910A000HR 61 fields · synced 24 Oct 2026