Skip to content

Serum Amyloid A (SAA) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

by Diasia Biomedical Technology Co., Ltd. 2 variants

Ref R331011, R331012, R331010Model 25 Tests/kit, 50 Tests/kit, 10 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973316742428 Basic UDI-DI Date10 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  • Withdrawn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

Device Name
Serum Amyloid A (SAA) Rapid Test Kit (Fluorescence Immunochromatographic Assay)
Model / Reference
25 Tests/kit, R331011, 50 Tests/kit, R331012, 10 Tests/kit, R331010
Primary DI / UDI-DI
06973316742428, 06973316742435, 06973316742411
Basic UDI-DI
B-06973316742428, B-06973316742435, B-06973316742411
EMDN Code
W01021199 Rheumatoid / inflammatory disease markers - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

See all devices from Diasia Biomedical Technology 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