EUDAMED device
Hedgehog™
EUDAMED device 00810000524280 · Parkell Inc.
Key facts
| Primary DI | 00810000524280 |
|---|---|
| Trade name | Hedgehog™ |
| Device name | HedgeHog Burs |
| Reference or catalog number | S497 |
| Manufacturer | Parkell Inc. |
| Manufacturer SRN | US-MF-000003761 |
| Risk class | Class I |
| EMDN code | L159007 |
| EMDN description | ODONTOSTOMATOLOGY BURS, REUSABLE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 29, 2026 |
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: