FDA Registration
Active
🇳🇱 Netherlands
Selectra ProS
Reg #: 8030478
·
FEI: 3001576181
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- VitalScientific B.V.
- Registration Number
- 8030478
- FEI Number
- 3001576181
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VAN RENSSELAERWEG 4
- City
- SPANKEREN Gelderland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K102647
Owner / Operator
- Firm Name
- VitalScientific B.V.
- Operator Number
- 8030479
- Address
- Van Rensselaerweg 4
- City
- Spankeren
- State
- Gelderland
- Postal Code
- 6956 AV
- Country
- NL
- Correspondent
- Adriaan P Intveld
US Agent
- Business Name
- Clinical Diagnostic Solutions, Inc
- Contact Name
- Junelle Goldson
- Address
- 1800 Nw 65th Ave
- City
- Plantation
- State
- FL
- ZIP
- 33313
- Country
- US
- [email protected]
- Phone
- 954 7911773
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2011-03-31 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2011-03-31 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2011-03-31 |
Proprietary Names
Selectra ProS
Selectra ProM
Viva-ProE
Establishment Types
Manufacture Medical Device