- Role
- Country
- Date of registration
- Address
Data from EUDAMED, last updated Jul 31, 2026
805360894SFT-HIGD4 references
805360894SFT-HIGDNo 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.
W0201010192Chemistry analysers - IVD medical device softwareW0201020192Automated immunochemistry analysers - IVD 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 |
|---|---|---|---|---|---|
| Software Hi | Software Hi | SFT-HI | 80536089418260 | 1 | On the market |
| Software Hi Version 1.2 | Software Hi Version 1.2 | SFT-HI01-02 | 80536089418192 | 1 | On the market |
| Software Hi Version 1.4 | Software Hi Version 1.4 | SFT-HI01-04 | 80536089418024 | 1 | On the market |
| Software Hi Version 1.5 | Software Hi Version 1.5 | SFT-HI01-05 | 80536089417966 | 1 | On the market |