Regulatory status by region| Region | Framework | Device class | Reference | Status |
|---|
| European Union | EU MDR 2017/745 | Class IIa / IIb | NB 0123 · CE 748291 | Registered |
|---|
| United States | FDA 510(k) | Class II | K243117 | Cleared |
|---|
| United Kingdom | UKCA | Class IIa | AB 0086 · UK 31204 | Registered |
|---|
| Brazil | ANVISA RDC 751 | Class III | Submission 25351.204 | Under review |
|---|
| Gulf states | SFDA / MOHAP | Class B / C | MDMA-2024-1187 | Registered |
|---|
| Southeast Asia | ASEAN AMDD | Class B / C | SG DE-0442 | Registered |
|---|
Quality system ISO 13485:2016, certificate 0123-QS-1180, issued by notified body 0123. Reference numbers shown are specimen values for this demonstration — replace with the issued certificate, clearance and registration numbers before publication so buyers can verify them independently.