Data from EUDAMED, last updated Aug 20, 2026
426043094OPALSETGS2 references
426043094OPALSETGSNo device characteristics flagged
Basic 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 →European Medical Device Nomenclature — the EU product classifications carried across this device family's references.
F0399Dialysis kits - other2 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 |
|---|---|---|---|---|---|
| OPAL® II Behandlungsset Classic | OPAL® II Behandlungsset Classic | 80003-II | 04260430940628 | 1 | On the market |
| OPAL® II Treatment Set MC5 | OPAL® II Treatment Set MC5 | 80003-II-MC5 | 04260430940840 | 1 | On the market |