EUDAMED device
CoolSculpting Elite Control Unit
EUDAMED device 00816417022326 · Zeltiq Aesthetics, Inc.
Key facts
| Primary DI | 00816417022326 |
|---|---|
| Trade name | CoolSculpting Elite Control Unit |
| Device name | CoolSculpting Elite System |
| Reference or catalog number | CS-S3-001-I-00 |
| Manufacturer | Zeltiq Aesthetics, Inc. |
| Manufacturer SRN | US-MF-000004536 |
| Risk class | Class IIb |
| EMDN code | M9001 |
| EMDN description | CRYOTHERAPY AND THERMOTHERAPY DEVICES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 5, 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: