Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030478

FEI Number

3001576181

Entity Name

VitalScientific B.V.

City/State/Country

SPANKEREN Gelderland, NL

Establishment Address

VAN RENSSELAERWEG 4, SPANKEREN Gelderland 6956 AV, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VitalScientific B.V. (Owner Number: 8030479)

Owner / Operator Contact Address

Van Rensselaerweg 4, Spankeren, NL-GE 6956 AV, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Selectra Mach5 Microlab 300 275-001 Carbon Dioxide Electrode, 278-001 Sodium Electrode, 279-001 Potassium Electrode, 280-001 Chloride Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-10-12
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2002-03-13
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2025-09-11
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2025-09-11
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2025-09-11
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2025-09-11

Official Correspondent

Adriaan Intveld

US Agent Details

Junelle Goldson Business: Clinical Diagnostic Solutions, Inc Email: junelle.goldson@boule.com Phone: (954) 7911773

Related Public Records

Same Entity

VitalScientific B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	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 measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

Similar Registrations

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030478. Last updated year: 2026. Please use registration number 8030478 when referencing this establishment in official correspondence.