Data from EUDAMED, last updated Jul 14, 2026
0858724003KET0563D6 references
0858724003KET0563DBasic 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.
W0102090199Drugs of abuse - otherW0102152009Controls for narcotics / toxicologyW0102152209Drugs of abuse / toxicology standards and calibrators6 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 |
|---|---|---|---|---|---|
| ARK Ketamine Assay | ARK Ketamine Assay | 5056-0001-00 | 00812101030004 | 1 | On the market |
| ARK Ketamine Assay | ARK Ketamine Assay | 5056-0001-01 | 00812101030011 | 1 | On the market |
| ARK Ketamine Calibrator | ARK Ketamine Calibrator | 5056-0002-01 | 00812101030035 | 1 | On the market |
| ARK Ketamine Calibrator | ARK Ketamine Calibrator | 5056-0002-02 | 00812101030042 | 1 | On the market |
| ARK Ketamine Calibrator | ARK Ketamine Calibrator | 5056-0002-00 | 00812101030028 | 1 | On the market |
| ARK Ketamine Control | ARK Ketamine Control | 5056-0003-00 | 00812101030059 | 1 | On the market |