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IMMUNODIAGNOSTIC SYSTEMS FRANCE

France·FR-MF-000023843

Last updated May 30, 2026

What IMMUNODIAGNOSTIC SYSTEMS FRANCE makes

The company produces in vitro diagnostic (IVD) devices for clinical chemistry analysis in laboratory settings, including automated systems and disposable cuvettes for biochemical assays. Their portfolio includes multi-discipline analysers designed for high-throughput testing, as well as reaction cuvettes for specific diagnostic measurements. These devices are intended for use in hospital and reference laboratories to measure substances such as electrolytes, enzymes, and other biomarkers.

The company’s devices are classified under EU Class A and Class I categories, with listings in the EUDAMED registry and the FDA’s Unique Device Identifier (UDI) database. Their products are intended for compliance with European IVD Regulation (IVDR) and U.S. FDA requirements, reflecting their global regulatory scope. The manufacturer is based in France.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
France
Address
42, Rue Stéphane MAZEAU, POUILLY EN AUXOIS, France
LinkedIn
—
Facebook
—
Phone
+33380905252
PRRC Contact
Céline ROUSSEAU
EUDAMED SRN
FR-MF-000023843
FDA FEI Number
—
DUNS Number
381472984

Catalogue (5)

DeviceModel / ReferenceRegistriesClassStatus
IDS-iSYS Cuvettes IS-CC100
FDA UDI
Class IActive
Reaction Cuvette 41402
EUDAMED
Class AActive
Zenit Ra 42675
EUDAMED
Class AActive
IDS-iSYS Multi-Discipline Automated System IS-310400
EUDAMED
Class AActive
Tgs Ta TGS00001
EUDAMED
Class AActive

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