EUDAMED device
Comfortgel Hot/Cold Therapy Mitt
EUDAMED device 00768627011365 · North Coast Medical Inc.
Key facts
| Primary DI | 00768627011365 |
|---|---|
| Trade name | Comfortgel Hot/Cold Therapy Mitt |
| Device name | Comfortgel Hot/Cold Therapy |
| Reference or catalog number | NC13253 |
| Model | 4411 |
| Manufacturer | North Coast Medical Inc. |
| Manufacturer SRN | US-MF-000009087 |
| Risk class | Class I |
| EMDN code | M9001 |
| EMDN description | CRYOTHERAPY AND THERMOTHERAPY DEVICES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 29, 2025 |
At a glance
- No 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: