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Serum Amyloid A Proteins (SAA) Test Kit (Quantum Dots Fluorescence Immunochromatography)

by Nanjing Vazyme Medical Technology Co., Ltd. 6 variants

Ref C3402CVModel C3402CV, C3403CV, C3402CC, C3404CC, C3403CC, C3402CL

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979469760197 Basic UDI-DI 06979469760197UDI-DIDate15 May 2026RegisteredStatusActive

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  • Withdrawn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
C3402CV, C3403CV, C3402CC, C3404CC, C3403CC, C3402CL
Primary DI / UDI-DI
06979469760197
Basic UDI-DI
B-06979469760197
EMDN Code
W01021199 Rheumatoid / inflammatory disease markers - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000031032
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Nanjing Vazyme Medical Technology Co., Ltd.

See all devices from Nanjing Vazyme Medical Technology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No