AQUATOOLS
FR-MF-000028808 · France · Paris
AQUATOOLS is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 92 |
|---|
Most frequent device types declared: FILTRAY, FILTRAY Compact.
Among these devices, 41 are declared sterile.
Devices declared under this manufacturer
- BIOFIL
- FILTRAY
- FILTRAY Compact
Showing 12 of 92 declared devices.
Catalogue references include AT030724, AT030742, AT030777, AT20161, AT20250, AT20350.
European nomenclature codes declared: A0499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AQUA-TOOLS (FR) · FDA 3014640782 |
| Devices in EUDAMED | 92 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 92 |
|---|---|
| Found in the U.S. device database | 16 |
| Share | 17.4 % |
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. AQUATOOLS is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40035 | supplemented | 2028-02-01 |
39236 | supplemented | 2028-02-01 |