Identity
- Device Name
- RIDA qLine® Soft EUDAMED
- Model / Reference
- Z9995 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095260780 EUDAMED04049095260636 EUDAMED04049095260254 EUDAMED
- Basic UDI-DI
- 4049095Z999500000MW EUDAMED
- EMDN Code
- W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
RIDA qLine® Soft by R-Biopharm AG — Class A — 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 | 4049095Z999500000MW | Class A | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (3)
- EUDAMED 97223914-97bc-447b-981c-3cf3ef0e1aa2 61 fields · synced Jul 29, 2026
- EUDAMED 633220b1-a170-46f6-8c80-f3bd0efa7c40 61 fields · synced May 19, 2026
- EUDAMED 242a95a0-6ae4-4f23-8b97-1e9ecdc745fb 61 fields · synced May 19, 2026