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Nucleic Acid Amplification and Detection Analyzer

by Ustar Biotechnologies (Hangzhou) Ltd. China EUDAMED

Ref U30014Model UC0116

EMDN W02050301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697349224U3000142A000EF Basic UDI-DIDate16 Jun 2022RegisteredStatusActive

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
Nucleic Acid Amplification and Detection Analyzer
Model / Reference
UC0116, U30014
Primary DI / UDI-DI
06973492240251
Basic UDI-DI
697349224U3000142A000EF
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.

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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 962a4416-ca6d-4fa9-ba7d-3eb389e809f3 61 fields · synced 24 Oct 2026