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Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)

EUDAMED

Class IVD General (EU MDR)

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

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

Identity

Trade Name
Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Device Name
Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
25 Tests/Kit EUDAMED
100 Tests/Kit EUDAMED
50 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06974986814590 EUDAMED
06974986814613 EUDAMED
06974986814606 EUDAMED
Basic UDI-DI
B-06974986814590 EUDAMED
B-06974986814613 EUDAMED
B-06974986814606 EUDAMED
EMDN Code
W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL 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

Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 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 ed5efcd7-2873-425c-b11d-c8f296787b90 61 fields · synced Oct 6, 2026
  • EUDAMED 290ec2ed-f5d1-4541-be50-057031d0395e 61 fields · synced May 17, 2026
  • EUDAMED 37f20ea8-3d6e-4f7a-a619-ce1ffc76e18c 61 fields · synced May 17, 2026