← Back to catalogue
RIDASCREEN® Rotavirus
EUDAMEDClass B (EU MDR)
Ref C0901K02-VKRef C0901C01-VKRef C0901
Identity
- Device Name
- RIDASCREEN® Rotavirus EUDAMED
- Model / Reference
- C0901K02-VK EUDAMEDC0901C01-VK EUDAMEDC0901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030567 EUDAMED04049095030543 EUDAMED04049095030024 EUDAMED
- Basic UDI-DI
- 4049095C090100000L4 EUDAMED
- EMDN Code
- W0105040606 ROTAVIRUS 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® Rotavirus 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 | 4049095C090100000L4 | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (3)
- EUDAMED 4ac52a61-b505-4ffa-a54a-ea7ae08c4088 61 fields · synced Oct 6, 2026
- EUDAMED ccd4b4e3-dcd2-462e-9dc6-51df2e616da2 61 fields · synced May 16, 2026
- EUDAMED 423d1d94-b6ac-4464-a7e2-119fe4b75f31 61 fields · synced May 17, 2026