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Reaction cup

by Jiangsu Confidence Medical Technology Co., Ltd

Ref 10 tests/kit

Active European Union

CE IVDR 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 Number69793559213HC10AX Basic UDI-DI 06979355922524UDI-DIDate30 Dec 2025RegisteredStatusActive
European UnionCE/IVDR Number69793559213HC10AX Basic UDI-DI 06979355922524UDI-DIDate30 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  • Withdrawn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, CE/IVDR Active

Specification

EUDAMED

Device Name
Reaction cup
Thymidine Kinase 1 (TK1) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
Model / Reference
10 tests/kit
Primary DI / UDI-DI
06979355922524
Basic UDI-DI
69793559213HC10AX, B-06979355922524
Direct Marketing DI
06979355922524
EMDN Code
W0599, W0102039008
Device Class
Class A
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
  • New Device

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