GERGONNE INDUSTRIE
FR-MF-000003647 · France · Oyonnax
GERGONNE INDUSTRIE is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 16 |
|---|
Among these devices, 15 are declared sterile.
Devices declared under this manufacturer
- BAXTER PLASTER
- IRIS
- MINIMOZ
- MOZAIK
- OSMOZ
- PAPYRUS
- SOLUKAT
- SOLUKAT ONE WEEK
- SOLUKAT SI
Showing 12 of 16 declared devices.
Catalogue references include 9921633000, PADIRIS-2, PADM100, PADM1000, PADS1000, PADS1000SI.
European nomenclature codes declared: M030404, M04010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GERGONNE INDUSTRIE (FR) · FDA 3013685003 |
| Devices in EUDAMED | 16 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. GERGONNE INDUSTRIE is registered in the United States but was not found in the Canadian register.