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Syphilis Antibody Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref G11834Model 25 tests/box
Identity
- Trade Name
- Syphilis Antibody Rapid Test Kit EUDAMED
- Device Name
- Syphilis Antibody Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG11834 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580835 EUDAMED
- Basic UDI-DI
- 697518250G118343E EUDAMED
- Direct Marketing DI
- 06942293580835 EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
New Device
Yes
EUDAMED
Syphilis Antibody Rapid Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250G118343E | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 8cf45d0b-2eab-4bf2-ba1e-9f21276254d0 61 fields · synced Oct 6, 2026