Identity
- Device Name
- RIDASCREEN® Legionella EUDAMED
- Model / Reference
- C8001C00-VK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030819 EUDAMED
- Basic UDI-DI
- 4049095C800100000LH EUDAMED
- EMDN Code
- W0105010501 LEGIONELLA ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class C 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® Legionella by R-Biopharm AG — Class C — 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 | 4049095C800100000LH | Class C | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (1)
- EUDAMED cd09e89e-f6af-4b2a-b928-5a575cabbd6c 61 fields · synced Jun 19, 2026