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RIDASCREEN® Astrovirus
EUDAMEDClass B (EU MDR)
Ref C1301K02-VKRef C1301Ref C1301K01-VK
Identity
- Device Name
- RIDASCREEN® Astrovirus EUDAMED
- Model / Reference
- C1301K02-VK EUDAMEDC1301 EUDAMEDC1301K01-VK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030680 EUDAMED04049095030062 EUDAMED04049095030673 EUDAMED
- Basic UDI-DI
- 4049095C130100000H9 EUDAMED
- EMDN Code
- W0105040629 ASTROVIRUS 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® Astrovirus 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 | 4049095C130100000H9 | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (3)
- EUDAMED e2c8a75c-0469-43ce-85b2-3509a00e7cbd 61 fields · synced Oct 6, 2026
- EUDAMED 261c7efb-3007-40ea-8f5a-30649912d211 61 fields · synced May 17, 2026
- EUDAMED 84cd4561-f65a-4bc8-9834-8cc89fd4590d 61 fields · synced May 18, 2026