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Progesterone (Prog) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)

by Jiangsu Confidence Medical Technology Co., Ltd EUDAMED 5 variants

Active European Union

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

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979355926065 Basic UDI-DIDate19 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Progesterone (Prog) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)
Model / Reference
100 tests/kit (including control), 50 tests/kit, 25 tests/kit (including control), 25 tests/kit, 25 tests/kit (including calibration), 100 tests/kit (including calibration)
Primary DI / UDI-DI
06979355926065, 06979355925969, 06979355926010, 06979355925952, 06979355925983, 06979355926003
Basic UDI-DI
B-06979355926065, B-06979355925969, B-06979355926010, B-06979355925952, B-06979355925983, B-06979355926003
EMDN Code
W0102050106, W0102050110
Device Class
Class IVD General
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

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