WAW Duo FUE System: 1 catalogue number listed by Devroye Instruments Belgium, under Motor, Surgical Instrument, Ac-Powered. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for WAW Duo FUE System | Listed by | Devroye Instruments Belgium |
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Premarket notification | Exempt |
| Record published | 2025-05-09 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 105 KiloPascal; Storage environment humidity 10 to 65 % RH; Storage environment temperature -5 to 40 °C; Handling environment atmospheric pressure 50 to 105 KiloPascal; Handling environment humidity 10 to 65 % RH; Handling environment temperature 10 to 40 °C |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.