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Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immuno…

EUDAMED

Class IVD General (EU MDR)

Ref 100 Tests/KitRef 50 Tests/KitModel 50 Tests/KitRef 25 Tests/Kit

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

Identity

Trade Name
Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Device Name
Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
100 Tests/Kit EUDAMED
50 Tests/Kit EUDAMED
25 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06974986814972 EUDAMED
06974986814965 EUDAMED
06974986814958 EUDAMED
Basic UDI-DI
B-06974986814972 EUDAMED
B-06974986814965 EUDAMED
B-06974986814958 EUDAMED
EMDN Code
W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immuno… by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
EUDAMED SRN
CN-MF-000027340
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED f338ba60-275e-4361-853a-9e71c2c2206a 61 fields · synced Oct 6, 2026
  • EUDAMED 4773d1ac-1edf-42cc-a323-ad50bdc4757c 61 fields · synced May 16, 2026
  • EUDAMED fcff2075-f243-49ce-95f1-0cbb2f815ef1 61 fields · synced May 18, 2026