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Risk classification and related examples of medical devices.
| Class | Risk | Examples |
|---|---|---|
| I | Low | Examination gloves, colostomy bags or oxygen masks |
| IIa | Low/medium | Hearing aids, urinary and peripheral vascular catheters |
| IIb | Medium/high | Ventilators and intensive care monitoring equipment |
| III | High | Implants, balloon catheters, pacemakers |
