← Back to catalogue
SYSTEM SOLUTION For Viva Drug Testing System
EUDAMEDFDA UDIClass A (EU MDR)
Ref 3203-063Ref SLSY-5905
Identity
- Trade Name
- SYSTEM SOLUTION For Viva Drug Testing System EUDAMEDFDA UDISYSTEM SOLUTION EUDAMED
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- SYSTEM SOLUTION For Viva Drug Testing System EUDAMEDSYSTEM SOLUTION EUDAMED
- Model / Reference
- 3203-063 EUDAMEDFDA UDISLSY-5905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540217500 EUDAMEDFDA UDI03661540217432 EUDAMED
- Basic UDI-DI
- 36615403203-06306YP EUDAMED3661540SLSY06XQ EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SYSTEM SOLUTION For Viva Drug Testing System by Vitalscientific — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 36615403203-06306YP | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (3)
- EUDAMED a9c196c9-1d75-4749-a9e2-cedfcc3c7a4c 61 fields · synced Jul 18, 2026
- FDA UDI 683930df-b1e8-43f7-b868-06819d8ad73e 32 fields · synced May 29, 2026
- EUDAMED da459323-9499-4cb9-b0fd-dc8356675222 61 fields · synced Jul 18, 2026