| Medical device law | |
|---|---|
| Medical device class | MDR I |
| Certificates | No certification |
| Legal Manufacturer | Fabrication Enterprises Inc. 250 Clearbrook Rd Ste 240 Elmsford NY 10523 |
| CH importer | MedEnvoy, Gotthardstrasse 28, 6302 Zug |
| CH authorized representative | AJW Technology Consulting GmbH |
| classification | |
| Product category | Medical device |
| Dimensions | |
| Thickness | Strong |
| Material & Care | |
| Color | Blue |