EU → North America Device Access

Cisbio Bioassays

FR-MF-000024051 · France · Codolet

Cisbio Bioassays is registered in the European database on medical devices as a manufacturer, with 57 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Among these devices, 2 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 57 declared devices.

Catalogue references include 17-OHP-CT, 30176061, CEA-RIACT, HGH-RIACT, OCFD03-FT4, OCPG57-T4.

European nomenclature codes declared: W0102039014, W01020402, W0102120104, W01020405, W01020407, W01020410.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED57
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN57
Found in the U.S. device database1
Share1.8 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCISBIO BIOASSAYS

North American profile: Canada only. Cisbio Bioassays holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in France

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