- Role
- Country
- Date of registration
- Address
Data from EUDAMED, last updated Jul 23, 2026
0827002WCM00000000048N47 references
0827002WCM00000000048N4Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →European Medical Device Nomenclature — the EU product classifications carried across this device family's references.
G03040201Papillotomes / sphincterotomes, double-lumenG03040202Papillotomes / sphincterotomes, triple (or more) lumen7 references
| Product | Trade name | Reference / catalog number | Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary → | Quantity | Status |
|---|---|---|---|---|---|
| D.A.S.H® DomeTip® Double Lumen Sphincterotome | D.A.S.H® DomeTip® Double Lumen Sphincterotome | DASH-35 | 00827002541931 | 1 | On the market |
| Fusion® OMNI-TOME | Fusion® OMNI-TOME | FS-OMNI-21 | 00827002486751 | 1 | On the market |
| Fusion® OMNI-TOME Sphincterotome | Fusion® OMNI-TOME Sphincterotome | FS-OMNI | 00827002319035 | 1 | On the market |
| Fusion® Triple Lumen Sphincterotome | Fusion® Triple Lumen Sphincterotome | FS-25M-35 | 00827002315334 | 1 | On the market |
| Howell D.A.S.H® Sphincterotome | Howell D.A.S.H® Sphincterotome | DASH-1 | 00827002252240 | 1 | On the market |
| Howell D.A.S.H® Sphincterotome | Howell D.A.S.H® Sphincterotome | DASH-21 | 00827002268500 | 1 | On the market |
| SureTome™ SW Sphincterotome with DomeTip® | SureTome™ SW Sphincterotome with DomeTip® | SUR-SW-35 | 00827002613508 | 1 | On the market |