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RIDASCREEN® Helicobacter
EUDAMEDClass B (EU MDR)
Ref C2302K01-VKRef C2302C01-VKRef C2302K02-VKRef C2302
Identity
- Device Name
- RIDASCREEN® Helicobacter EUDAMED
- Model / Reference
- C2302K01-VK EUDAMEDC2302C01-VK EUDAMEDC2302K02-VK EUDAMEDC2302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030796 EUDAMED04049095030789 EUDAMED04049095030802 EUDAMED04049095030406 EUDAMED
- Basic UDI-DI
- 4049095C230200000JD EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION 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® Helicobacter 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 | 4049095C230200000JD | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (4)
- EUDAMED b0fae7c8-28da-4585-95a5-38121830127a 61 fields · synced Jul 30, 2026
- EUDAMED 74b512a6-32aa-47bc-bad8-4e46786b3160 61 fields · synced May 17, 2026
- EUDAMED 68d46c2b-9cc6-4b80-927a-19cc168f1130 61 fields · synced May 17, 2026
- EUDAMED 40eae25d-1c08-4015-b0f1-d87b2028360c 61 fields · synced May 18, 2026