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Triiodothyronine/ Thyroxine/Thyroid stimulating hormone (T3/T4/TSH) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

by Jiangsu Confidence Medical Technology Co., Ltd 4 variants

Ref 100 tests/kit, 1 test/kit, 40 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-06979355921664 Basic UDI-DI Date15 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  • Withdrawn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
Triiodothyronine/ Thyroxine/Thyroid stimulating hormone (T3/T4/TSH) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
Thyroid stimulating hormone (TSH) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
Model / Reference
100 tests/kit, 1 test/kit, 40 tests/kit
Primary DI / UDI-DI
06979355921664, 06979355923811, 06979355921619, 06979355921640, 06979355923866
Basic UDI-DI
B-06979355921664, B-06979355923811, B-06979355921619, B-06979355921640, B-06979355923866
EMDN Code
W01020405, W01020410
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

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