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DrugFor™ Urine Multi-Drug Test Cup
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref VDDOA02
Identity
- Trade Name
- DrugFor™ Urine Multi-Drug Test Cup EUDAMED
- Device Name
- Urine Multi-Drug Test Cup EUDAMED
- Model / Reference
- VDDOA02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548251503 EUDAMED
- Basic UDI-DI
- B-08683548251503 EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
DrugFor™ Urine Multi-Drug Test Cup by Vitrosens Biotechnology Inc. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232228 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08683548251503 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 9621d10e-e7f9-44dc-96e8-ed68614193b4 61 fields · synced Oct 6, 2026
- FDA 510(k) K232228 1 fields · synced May 18, 2026