Data from EUDAMED, last updated Jul 23, 2026
B-006083370010681 reference
B-00608337001068PS-075-2, 3, 5, CDC#1934 Combined Study ReportPS-075-7PS-075-10 DGM-585DGM-586OQ-OTC-4Basic 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.
W0105090302Hiv 1 / 2 - rt & poc1 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 |
|---|---|---|---|---|---|
| OraQuick HIV Self-Test | OraQuick HIV Self-Test | 1001-0630U | 00608337001068 | 1 | On the market |