Biomedical Diagnostics (Bmd) SA
FranceFDA applicant, unverified
- Devices
- 10
What Biomedical Diagnostics (Bmd) SA makes
Biomedical Diagnostics (Bmd) SA manufactures in vitro diagnostic devices for autoimmune and genetic testing, including the FIDIS Connective 10 and Connective 8 assays for connective tissue disorders, the FIDIS Thyroid (MX002) for thyroid-related markers, and the FIDIS Celiac assay for celiac disease screening. The company also produces the FIDIS Vascularitis assay (MX007) and its modification, along with the FIDIS dsDNA test for systemic lupus erythematosus. These products are designed for laboratory use with analyzer systems and CARIS software integration.
The company’s diagnostic devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight. The portfolio is not registered in other major regulatory databases.
Catalogue
Fidis Connective 10, Model MX006 Ref K053653
Regimes: 510(k) Registry: 510(k)Fidistm Connective 10, Fidistm Analyzer, Caris Ref K102607
Regimes: 510(k) Registry: 510(k)Fidis Dsdna Ref K060380
Regimes: 510(k) Registry: 510(k)Fidis Tm Thyro, Model MX002 Ref K061794
Regimes: 510(k) Registry: 510(k)Modification To Fidis Vasculitis, Model MX007 Ref K070458
Regimes: 510(k) Registry: 510(k)Fidis Celiac Ref K053383
Regimes: 510(k) Registry: 510(k)Fidis Vasculitis, Model MX007 Ref K053012
Regimes: 510(k) Registry: 510(k)Fidis Connective 8 Ref K050286
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biomedical Diagnostics (Bmd) SA have in the registry?
The registry currently lists 10 devices for Biomedical Diagnostics (Bmd) SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomedical Diagnostics (Bmd) SA's devices?
Among its 10 most recently registered devices, Biomedical Diagnostics (Bmd) SA has devices listed in FDA 510(k) (10 devices).
What risk classes do Biomedical Diagnostics (Bmd) SA's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Biomedical Diagnostics (Bmd) SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomedical Diagnostics (Bmd) SA in the registry?
The most recently registered devices listed for Biomedical Diagnostics (Bmd) SA include FIDIS CONNECTIVE 10, MODEL MX006, FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS, FIDIS DSDNA and FIDIS TM THYRO, MODEL MX002.