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RIDASCREEN® Giardia
EUDAMEDClass B (EU MDR)
Ref C1101K01-VKRef C1101C01-VKRef C1101Ref C1101K02-VK
Identity
- Device Name
- RIDASCREEN® Giardia EUDAMED
- Model / Reference
- C1101K01-VK EUDAMEDC1101C01-VK EUDAMEDC1101 EUDAMEDC1101K02-VK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030611 EUDAMED04049095030604 EUDAMED04049095030048 EUDAMED04049095030628 EUDAMED
- Basic UDI-DI
- 4049095C110100000G3 EUDAMED
- EMDN Code
- W0105050208 GIARDIA LAMBLIA 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® Giardia 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 | 4049095C110100000G3 | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (4)
- EUDAMED cec36e3e-ffb8-4b62-8de3-7caf51917e45 61 fields · synced Oct 5, 2026
- EUDAMED 12f5009f-3239-4877-9bf1-d8d0fc5d8ced 61 fields · synced May 18, 2026
- EUDAMED 2dcf351b-c3c9-406a-9369-d29ccc02d36b 61 fields · synced May 18, 2026
- EUDAMED 2f2ded3e-a68e-47c1-b9c8-dcec21c593b2 61 fields · synced May 19, 2026