- Role
- Country
- Date of registration
- Address
Data from EUDAMED, last updated Jul 14, 2026
0858724003FEN069Y86 references
0858724003FEN069Y8Basic 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 Fentanyl Calibrator | ARK Fentanyl Calibrator | 5031-0002-01 | 00858724003445 | 1 | On the market |
| ARK Fentanyl Calibrator | ARK Fentanyl Calibrator | 5031-0002-02 | 00858724003452 | 1 | On the market |
| ARK Fentanyl Control | ARK Fentanyl Control | 5031-0003-00 | 00858724003421 | 1 | On the market |
| ARK Fentanyl II Assay | ARK Fentanyl II Assay | 5069-0001-01 | 00812101030578 | 1 | On the market |
| ARK Fentanyl II Assay | ARK Fentanyl II Assay | 5069-0001-02 | 00812101030585 | 1 | On the market |
| ARK Fentanyl II Assay | ARK Fentanyl II Assay | 5069-0001-00 | 00812101030561 | 1 | On the market |