Lys Medical
BE-MF-000000036 · Belgium · Gosselies
Lys Medical is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- GS1519PS
- GS1619B
- GS1619BS
- GS2027BS
- Guide Sheaths Accessory Stoppers
- Iriscope EagleCath
- Iriscope GS 180
- Iriscope GS 90
- Iriscope Guide Sheath
- Iriscope Mini GS
- Iriscope Probe 1.8
- Iriscope Processor
Showing 12 of 20 declared devices.
Catalogue references include 0155, 0401, 0420, 0601, GS-20-27-B, GS1519PS.
European nomenclature codes declared: Z12020885, Z12020802, Z12020880, Z12020406,Z12020880.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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. Lys Medical was not found in either the U.S. or the Canadian register.