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Human Epididymis Protein 4 (HE4) Assay Kit (Chemiluminescent Immunoassay)

by Wuhan Life Origin Biotech Joint Stock Co., Ltd. 2 variants

Ref 50 Tests/Kit, 100 Tests/Kit, DD0601Model 2×50 test/box Calibrator:0.5mL×2

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974986813234 Basic UDI-DI Date19 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Trade Name
Human Epididymis Protein 4 (HE4) Assay Kit (Chemiluminescent Immunoassay)
Human Epididymal Protein 4 (HE4) Assay Kit (Chemiluminescent Immunoassay)
Model / Reference
50 Tests/Kit, 100 Tests/Kit, 2×50 test/box Calibrator:0.5mL×2, DD0601
Primary DI / UDI-DI
06974986813234, 06974986813241, 06970522646205
Basic UDI-DI
B-06974986813234, B-06974986813241, B-06970522646205
EMDN Code
W0102030119 Human epididymis protein 4
Device Class
Class IVD General
EU market of registration
Austria
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000027340
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuhan Life Origin Biotech Joint Stock Co., Ltd.

See all devices from Wuhan Life Origin Biotech Joint Stock 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