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RPR carbon
EUDAMEDClass IVD General (EU MDR)
Ref 22152Model 22152 - 22152-500 - 22152S
Identity
- Trade Name
- RPR carbon EUDAMED
- Device Name
- RPR carbon EUDAMED
- Model / Reference
- 22152 - 22152-500 - 22152S EUDAMED22152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100813 EUDAMED
- Basic UDI-DI
- B-05404035100813 EUDAMED
- EMDN Code
- W0105010399 SYPHILIS REAGENTS OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
RPR carbon by Cypress Diagnostics — 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-05404035100813 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED f3a2e39a-dcc5-4dab-97a3-13e12d702bee 61 fields · synced Jun 18, 2026