Identity
- Device Name
- RBknee EUDAMED
- Model / Reference
- 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700002173645 EUDAMED
- Basic UDI-DI
- 57000021736RB01BG EUDAMED
- Direct Marketing DI
- 05700002173645 EUDAMED
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RBknee by Radiobotics ApS — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203696 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 57000021736RB01BG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Radiobotics ApS
- EUDAMED SRN
- DK-MF-000023156
Sources (2)
- EUDAMED 158cd71d-acbc-43b4-97d5-c51fce92c1de 61 fields · synced Jul 9, 2026
- FDA 510(k) K203696 1 fields · synced May 18, 2026