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Jet-iStar 800 Analyzer

by Joinstar Biomedical Technology Co., Ltd. EUDAMED

Active European Union

Ref JS800Model Jet-iStar 800

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69210267JS800GJ Basic UDI-DIDate12 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Jet-iStar 800 Analyzer
Model / Reference
Jet-iStar 800, JS800
Primary DI / UDI-DI
06921026705264
Basic UDI-DI
69210267JS800GJ
Direct Marketing DI
06921026705264
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000001083
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Joinstar Biomedical Technology Co., Ltd.

Properties

  • 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