EUDAMED device
OPAL HDx™
EUDAMED device 00191506055301 · Boston Scientific Corporation
Key facts
| Primary DI | 00191506055301 |
|---|---|
| Trade name | OPAL HDx™ |
| Device name | OPAL HDx™ Mapping System Workstation PC |
| Reference or catalog number | M004OPAL40100 |
| Manufacturer | Boston Scientific Corporation |
| Manufacturer SRN | US-MF-000004702 |
| Risk class | Class IIb |
| EMDN code | C020199 |
| EMDN description | CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 14, 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: