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Carcinoembryonic antigen (CEA) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)

by Jiangsu Confidence Medical Technology Co., Ltd 3 variants

Ref 50 tests/kit (including calibration), 50 tests/kit (including calibration and control), 25 tests/kit (including calibration and control), 100 tests/kit (including calibration and control), 25 tests/kit, 100 tests/kit, 5 tests/kit, 100 tests/kit (including calibration), 25 tests/kit (including 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-06979355920087 Basic UDI-DI Date16 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  • Withdrawn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
Carcinoembryonic antigen (CEA) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)
Model / Reference
50 tests/kit (including calibration), 50 tests/kit (including calibration and control), 25 tests/kit (including calibration and control), 100 tests/kit (including calibration and control), 25 tests/kit, 100 tests/kit, 5 tests/kit, 100 tests/kit (including calibration), 25 tests/kit (including control)
Primary DI / UDI-DI
06979355920087, 06979355920179, 06979355920056, 06979355920100, 06979355920186, 06979355920018, 06979355920032, 06979355920025, 06979355920063, 06979355920070
Basic UDI-DI
B-06979355920087, B-06979355920179, B-06979355920056, B-06979355920100, B-06979355920186, B-06979355920018, B-06979355920032, B-06979355920025, B-06979355920063, B-06979355920070
EMDN Code
W0102030112 Carcinoembryonic antigen
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

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Properties

  • Reagent
  • Professional Testing NoEUDAMEDYesEUDAMED

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