Identity
- Trade Name
- Syphilis Rapid Test EUDAMED
- Device Name
- Syphilis Rapid Test EUDAMED
- Model / Reference
- VISY-402 EUDAMEDVISY EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VISY-402XV EUDAMED06937339210142 EUDAMED
- Basic UDI-DI
- B-VISY-402XV EUDAMEDB-06937339210142 EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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 Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd. — 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-VISY-402XV | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 27dc9c3a-5e9a-4a6f-a018-3c32914194e9 61 fields · synced Jul 28, 2026
- EUDAMED e059932a-726d-4f3e-9c45-6e5494a86053 61 fields · synced Jul 28, 2026