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Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM/IgG Antibody (Colloidal Gold Method)

by Zhongshan Bio-Tech Co., Ltd.

Ref FR0301-25, FR0102-96Model 25 tests/kit, 96 tests/kit

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936791020061 Basic UDI-DI Date18 Oct 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM/IgG Antibody (Colloidal Gold Method)
Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM (ELISA)
Model / Reference
25 tests/kit, FR0301-25, 96 tests/kit, FR0102-96
Primary DI / UDI-DI
06936791020061, 06936791010086
Basic UDI-DI
B-06936791020061, B-06936791010086
EMDN Code
W0105040614 Hantavirus / bunyavirus
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028828
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Human Tissues NoEUDAMEDYesEUDAMED
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (5)

  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No