Skip to content

Beta amyloid protein 1-40 (Aβ1-40) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)

by Jiangsu Confidence Medical Technology Co., Ltd 9 variants

Ref 100 tests/kit (including control), 50 tests/kit (including control), 100 tests/kit, 50 tests/kit, 25 tests/kit (including calibration and control), 100 tests/kit (including calibration), 25 tests/kit, 100 tests/kit (including calibration and control), 50 tests/kit (including calibration), 50 tests/kit (including calibration and control)

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-06979355922975 Basic UDI-DI Date28 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  • Withdrawn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
Beta amyloid protein 1-40 (Aβ1-40) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)
Model / Reference
100 tests/kit (including control), 50 tests/kit (including control), 100 tests/kit, 50 tests/kit, 25 tests/kit (including calibration and control), 100 tests/kit (including calibration), 25 tests/kit, 100 tests/kit (including calibration and control), 50 tests/kit (including calibration), 50 tests/kit (including calibration and control)
Primary DI / UDI-DI
06979355922975, 06979355922906, 06979355921084, D-0697935592279149, 06979355923095, 06979355921176, D-069793559229824J, D-069793559228814B, D-069793559227774F, 06979355921107, 06979355921206, D-069793559227844C, 06979355921077, 06979355921190
Basic UDI-DI
B-06979355922975, B-06979355922906, B-06979355921084, B-0697935592279149, B-06979355923095, B-06979355921176, B-069793559229824J, B-069793559228814B, B-069793559227774F, B-06979355921107, B-06979355921206, B-069793559227844C, B-06979355921077, B-06979355921190
EMDN Code
W01021301, W01029099
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050949
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

Other devices from Jiangsu Confidence Medical Technology Co., Ltd

See all devices from Jiangsu Confidence Medical Technology Co., Ltd →

Properties

  • Reagent
  • Professional Testing YesEUDAMEDNoEUDAMED

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