- Role
- Country
- Date of registration
- Address
Data from EUDAMED, last updated Jul 17, 2026
++B618N18Z4 references
++B618N18ZBasic 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.
Y061899Upper extremity prostheses - otherZ12100480Electromyography instruments - hardware accessoriesZ12100492Electromyography instruments -medical device software4 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 |
|---|---|---|---|---|---|
| Coapt Evaluation Kit | Coapt Evaluation Kit | B618Q1 | B618Q1 | 1 | On the market |
| Complete Control System Gen2 | Complete Control System Gen2 | N1 | B618N1 | 1 | On the market |
| Dome Electrode | Dome Electrode | B618E0 | B618E0 | 18 | On the market |
| Gen2 System Kit | Gen2 System Kit | B618P1 | B618P1 | 1 | On the market |