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Rapid Syphilis Antibody Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref 1N02S2
Identity
- Trade Name
- Rapid Syphilis Antibody Test Strip EUDAMED
- Device Name
- Rapid Syphilis Antibody Test Strip EUDAMED
- Model / Reference
- 1N02S2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963710833 EUDAMED
- Basic UDI-DI
- B-06921963710833 EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Rapid Syphilis Antibody Test Strip by Xiamen Boson Biotech 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-06921963710833 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 357e94d8-e44d-4b9a-a25a-93cf9080016f 61 fields · synced Jun 18, 2026