← Back to catalogue
Syphilis Ab Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref Model: SYAb-25; Specification: 25 TestsModel SYAb-25
Identity
- Trade Name
- Syphilis Ab Rapid Test EUDAMED
- Model / Reference
- SYAb-25 EUDAMEDModel: SYAb-25; Specification: 25 Tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626469 EUDAMED
- Basic UDI-DI
- B-06974689626469 EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland 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
Syphilis Ab Rapid Test by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974689626469 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 79e51e54-0237-4c06-9b28-2bb9a0919d35 61 fields · synced Jun 18, 2026
- EUDAMED 79e51e54-0237-4c06-9b28-2bb9a0919d35-1 61 fields · synced Jun 10, 2026