Skip to content

Nucleic Acid Amplification and Detection Analyzer

by Ustar Biotechnologies (Hangzhou) Ltd. China EUDAMED

Ref U30003Model UC0102

EMDN W02050301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697349224U3000032A000DH Basic UDI-DIDate15 Jun 2022RegisteredStatusActive

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
Nucleic Acid Amplification and Detection Analyzer
Model / Reference
UC0102, U30003
Primary DI / UDI-DI
06973492240220
Basic UDI-DI
697349224U3000032A000DH
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
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
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 854a8cb6-f156-4770-9377-c0b162875b39 61 fields · synced 22 Oct 2026