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Treponema pallidum Antibody Rapid Qualitative Test
EUDAMEDClass IVD General (EU MDR)
Ref BT0102701
Identity
- Trade Name
- Treponema pallidum Antibody Rapid Qualitative Test EUDAMED
- Device Name
- Treponema pallidum Antibody Rapid Qualitative Test EUDAMED
- Model / Reference
- BT0102701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260207992 EUDAMED
- Basic UDI-DI
- B-06933260207992 EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Treponema pallidum Antibody Rapid Qualitative Test by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06933260207992 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED f0d28de9-fba0-4251-9be5-186a38899832 61 fields · synced Oct 6, 2026
- EUDAMED a11591ce-77f5-4f70-8d8a-0b0a8af129a1 61 fields · synced Jul 15, 2026