Identity
- Device Name
- RIDASCREEN® Entamoeba EUDAMED
- Model / Reference
- C1701C01-VK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030727 EUDAMED
- Basic UDI-DI
- 4049095C170100000KM EUDAMED
- EMDN Code
- W0105050201 ENTAMOEBA HISTOLYTICA EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
RIDASCREEN® Entamoeba by R-Biopharm AG — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4049095C170100000KM | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (1)
- EUDAMED 52077a67-cb20-4f93-ad2e-26d0f1792e43 61 fields · synced May 22, 2026