EUDAMED device
Custom Smart Seal BK 20-6
EUDAMED device 00713980012696 · Alps South, LLC
Key facts
| Primary DI | 00713980012696 |
|---|---|
| Trade name | Custom Smart Seal BK 20-6 |
| Device name | SMART SEAL LINER |
| Reference or catalog number | SBFR20-6-C |
| Manufacturer | Alps South, LLC |
| Manufacturer SRN | US-MF-000001260 |
| Risk class | Class I |
| EMDN code | Y062499 |
| EMDN description | LOWER EXTREMITY PROSTHESES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 23, 2024 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: