Data from EUDAMED, last updated Jul 31, 2026
B-084370169422911 reference
B-08437016942291CE 588493Basic 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.
W0106010104Fragile x syndrome1 reference
| 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 |
|---|---|---|---|---|---|
| Adellgene® Fragile X Screening 16 tests | Adellgene® Fragile X Screening 16 tests | AD-FX-16 | 08437016942291 | 1 | On the market |