Identity
- Device Name
- RIDA®TUBE Calprotectin EUDAMED
- Model / Reference
- GZ3016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095070198 EUDAMED
- Basic UDI-DI
- 4049095GZ30160000KS EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Category: General specimen collection kit
RIDA®TUBE Calprotectin by R-Biopharm AG — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4049095GZ30160000KS | Class A | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (1)
- EUDAMED 1b377828-444c-4ce7-b238-a781f3b3bb1e 61 fields · synced Jul 14, 2026