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Welleo B-hCG Professional Test

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

Ref 15 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08445982000969 Basic UDI-DI Date26 Jun 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  • Withdrawn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

Trade Name
Welleo B-hCG Professional Test
Welleo HbA1c Professional Test
Model / Reference
15 Tests/Kit
Primary DI / UDI-DI
08445982000969, 08445982000808
Basic UDI-DI
B-08445982000969, B-08445982000808
EMDN Code
W0102160302, W0102160102
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000027340
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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

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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