Data / Medical devices / Netherlands / VitalScientific B.V.
VitalScientific B.V.: FDA-registered device maker in SPANKEREN Gelderland, Netherlands, 1 510(k) clearance
VitalScientific B.V. is registered with the FDA (registration 8030478) in SPANKEREN Gelderland, Netherlands. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 24, 2011. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8030478
- FEI number
- 3001576181
- Address
- Van Rensselaerweg 4, SPANKEREN Gelderland, Netherlands, 6956 AV
- Owner or operator
- VitalScientific B.V. (8030479)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 13, 2002
- Registered through
- 2026
- Brand names listed
- 275-001 Carbon Dioxide Electrode, 278-001 Sodium Electrode, 279-001 Potassium Electrode, 280-001 Chloride Electrode, Microlab 300, Selectra Mach5, Selectra ProM, Selectra ProS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Manufacturer | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2011 | K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... | JGS | Substantially Equivalent | Elitechgroup Vital Scientific BV | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 7, 2018 | 83648 | Class II | Terminated | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to mea | The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned a | accessdata.fda.gov |
| July 12, 2016 | 83381 | Class III | Terminated | Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to | Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Ion Specific, Sodium
- All makers of Electrode, Ion Specific, Potassium
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Nadh Oxidation/Nad Reduction, Ast/Sgot
- All makers of Electrode, Ion-Specific, Chloride
Updated March 24, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.