| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Bedhekbeschermer 100 cm | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer 100 cm - met instopstrook | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer 100cm t.b.v. Sentida bed van 200cm (geschikt voor deelbare hekken 50/50) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer 110cm t.b.v. voeteneinde Sentida bed van 210cm (geschikt voor deelbare hekken 50/50) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer 198cm, 5 sluitingen | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer 198cm, 5 sluitingen - met instopstrook | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer 208cm, 5 sluitingen | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer hoofdeinde links/rechts te gebruiken t.b.v. FMB Formidabel Pro bed | 85x29 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer hoofdeinde t.b.v. FMB First bed | 92x26 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer voeteneinde links/rechts te gebruiken t.b.v. FMB Formidabel Pro bed 210cm | 121x29 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer voeteneinde links/rechts te gebruiken t.b.v. FMB Formidabel Pro bed 220cm | 129x29 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer voeteneinde t.b.v. FMB First bed 210cm | 107x26 | links & rechts te gebruiken | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Bedhekbeschermer voeteneinde t.b.v. FMB First bed 220cm | 117x26 | links & rechts te gebruiken | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| High flow 100-210 Heavy Duty | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| High flow 100 Heavy Duty | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| High flow 120 Heavy Duty | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| High flow 90 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| High Flow 90-210 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Medium flow 100 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Medium flow 90 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
Get alerts on new registrations, recalls, and regulatory changes.
