Luciole Medical AG
CH-MF-000015856 · Switzerland · Zurich (ZH)
Luciole Medical AG is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|---|
| Class I | 1 |
Most frequent device types declared: 20020.
Among these devices, 1 are declared sterile, 1 active, 2 with a measuring function.
Authorised representative in the Union: Veranex Germany GmbH.
Devices declared under this manufacturer
- RheoConnect 1.0 Dräger
- RheoConnect 1.0 Philips
- RheoControl
- RheoLity 2.6
- RheoPatch Knob with cable 2.0, 1 meter
- RheoPatch Knob with cable 2.0, 2 meters
- RheoPatch Knob with cable 2.0, 3 meters
- RheoPatch Sensor 2.0
- RheoSens
Catalogue references include 10030, 20020, 22010, 22110, 30020, 31020.
European nomenclature codes declared: Z12109006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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: Neither register. Luciole Medical AG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
7229GB448240322 | issued | 2027-07-15 |
13560GB450240322 | issued | 2029-03-21 |