Identity
- Device Name
- RIDA®UNITY EUDAMEDRIDA®UNITY Parasitic Stool Panel II EUDAMED
- Model / Reference
- ZUNITY EUDAMEDUN1725 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095260711 EUDAMED04049095260759 EUDAMED04049095210099 EUDAMED04049095260766 EUDAMED
- Basic UDI-DI
- 4049095ZUNITY0000PA EUDAMED4049095UN17250000SF EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMEDW0105050299 PARASITOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Rida®unity 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 | 4049095ZUNITY0000PA | Class A | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (4)
- EUDAMED ea5cf8bc-f231-4ac0-9539-0c5df913f1c2 61 fields · synced Jul 19, 2026
- EUDAMED 67705421-8cd1-44d8-9cdc-025a2dcab713 61 fields · synced May 16, 2026
- EUDAMED 3ec9bc43-01e9-4ca3-af96-950570daa6ea 61 fields · synced May 18, 2026
- EUDAMED 9847e70d-c2f6-4c0c-854b-15a72a5db1dc 61 fields · synced May 19, 2026