Skip to content

Human Epididymis Protein 4 (HE4) Rapid Quantitative Test

by Xenta Biomedical Science Co., Ltd. 2 variants

Ref XRDL052A120OS

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-06975278861087 Basic UDI-DI 06975278861087UDI-DIDate8 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Human Epididymis Protein 4 (HE4) Rapid Quantitative Test
Model / Reference
XRDL052A120OS
Primary DI / UDI-DI
06975278861087
Basic UDI-DI
B-06975278861087
EMDN Code
W0102030119 Human epididymis protein 4
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000057746
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Xenta Biomedical Science Co., Ltd.

See all devices from Xenta Biomedical Science Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Near-Patient Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No