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Chemiluminescence Immunoassay Analyzer

by Shenzhen Drawray Biotech Co., Ltd. 2 variants

Ref FD0228, FD0206, FG0054Model iStar 2000-A/ iStar 2000-B/ iStar 2000-C, iStar 500

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6973224890071AH Basic UDI-DI Date4 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Chemiluminescence Immunoassay Analyzer
Model / Reference
iStar 2000-A/ iStar 2000-B/ iStar 2000-C, FD0228, FD0206, iStar 500, FG0054
Primary DI / UDI-DI
06973224898354, 06973224892000, 06973224890259
Basic UDI-DI
6973224890071AH, 6973224890040A6
EMDN Code
W0201020102, W0201020101
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008763
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Drawray Biotech Co., Ltd.

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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