Axess Vision Technology
FR-MF-000003039 · France · JOUE LES TOURS
Axess Vision Technology is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 10 |
|---|
Most frequent device types declared: 10040001, 11010011, 30030001 , 30030000, Agile, Screeni.
Among these devices, 7 are declared sterile, 4 active.
Devices declared under this manufacturer
- Broncoflex Vortex
- Broncoflex XFlo
- Broncoflex® Agile
- Broncoflex™ Agile
- Broncoflex™ Vortex
- Cystoflex™ Reverse Deflection
- Cystoflex™ Standard Deflection
- Easy BAL Clip
- Screeni
- Screeni™
Catalogue references include 10030001, 10040001, 11010011, 11010012, 20030001, 30030000.
European nomenclature codes declared: Z12020802, Z11900880, Z12020701, V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AXESS VISION TECHNOLOGY (FR) · FDA 3017859830 |
| Devices in EUDAMED | 10 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 80.0 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | AXESS VISION TECHNOLOGY S.A.S |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-04-08 |
Licence types: System (1).
Licensed under: BRONCOFLEX.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FR25/00000104 | supplemented | 2030-04-29 |