EUDAMED device
Hydratome™
EUDAMED device 00191506039264 · Boston Scientific Corporation
Key facts
| Primary DI | 00191506039264 |
|---|---|
| Trade name | Hydratome™ |
| Device name | Sphincterotome |
| Reference or catalog number | M00584420 |
| Manufacturer | Boston Scientific Corporation |
| Manufacturer SRN | US-MF-000004702 |
| Risk class | Class IIb |
| EMDN code | G03040202 |
| EMDN description | PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Aug 27, 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: