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RPR carbon
EUDAMEDClass IVD General (EU MDR)
Ref 22152SModel 22152S - 22152 - 22152-500Ref 22152-500Model 22152-500 - 22152 - 22152S
Identity
- Trade Name
- RPR carbon EUDAMED
- Device Name
- RPR carbon EUDAMED
- Model / Reference
- 22152S - 22152 - 22152-500 EUDAMED22152S EUDAMED22152-500 - 22152 - 22152S EUDAMED22152-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100837 EUDAMED05404035100820 EUDAMED
- Basic UDI-DI
- B-05404035100837 EUDAMEDB-05404035100820 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
No
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
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-05404035100837 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (2)
- EUDAMED f1e064f2-6cf4-4767-8d28-0934687b6238 61 fields · synced Jul 17, 2026
- EUDAMED 93fccaf9-7788-472f-87b3-d026bc38d140 61 fields · synced May 19, 2026