EUDAMED device
Guardian
EUDAMED device 00195411041664 · College Park Industries, Inc.
Key facts
| Primary DI | 00195411041664 |
|---|---|
| Trade name | Guardian |
| Device name | External Prosthetic Knee |
| Reference or catalog number | CP KTCS 25 |
| Manufacturer | College Park Industries, Inc. |
| Manufacturer SRN | US-MF-000002352 |
| Risk class | Class I |
| EMDN code | Y062415 |
| EMDN description | TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 15, 2025 |
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: