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Rapid Test for Antibody to Syphilis (Colloidal Gold Device)
EUDAMEDClass IVD General (EU MDR)
Ref WJ-1610, WJ-1610E
Identity
- Device Name
- Rapid Test for Antibody to Syphilis (Colloidal Gold Device) EUDAMED
- Model / Reference
- WJ-1610, WJ-1610E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970301452577 EUDAMED
- Basic UDI-DI
- B-06970301452577 EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Rapid Test for Antibody to Syphilis (Colloidal Gold Device) by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. — Class IVD General — IVDD — listed in…
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-06970301452577 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000040626
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED ee68745d-9b75-487f-bd25-77ad549bc8de 61 fields · synced Oct 5, 2026
- EUDAMED ee68745d-9b75-487f-bd25-77ad549bc8de-1 61 fields · synced Jun 10, 2026