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iStar-GADA

by Hunan Drawray Biotech Co., Ltd.

Ref DC76065Model 30 Tests

Active European Union

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DC76065FP Basic UDI-DI D-DC76065FPUDI-DIDate25 Dec 2025RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
30 Tests, DC76065
Primary DI / UDI-DI
D-DC76065FP
Basic UDI-DI
B-DC76065FP
EMDN Code
W0102060105 Gad II antibodies and other ica
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000020269
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hunan Drawray Biotech Co., Ltd.

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No