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Welleo CRP Professional Test

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

Active European Union

Ref 15 Tests/Kit

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08445982000853 Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
Welleo CRP Professional Test
Welleo Vitamin D Professional Test
Welleo LH Professional Test
Model / Reference
15 Tests/Kit
Primary DI / UDI-DI
08445982000853, 08445982001058, 08445982000983
Basic UDI-DI
B-08445982000853, B-08445982001058, B-08445982000983
EMDN Code
W0102160601, W0102070206, W0102160304
Device Class
Class IVD General
Market of Registration
Austria

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