Sedana Medical Limited
IE-MF-000001734 · Ireland · Naas
Sedana Medical Limited is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: FlurAbsorb Pro-L, Reusable Abbvie QuikFil® Adapter, Scavenging Tube, Sedaconda® ACD-S.
Devices declared under this manufacturer
- FlurAbsorb Pro-L
- FlurAbsorb Pro-S
- Mindray Exhaust Connector
- Reusable Abbvie QuikFil® Adapter
- Reusable Baxter S-T-S® Adapter
- Reusable Piramal SPC Adapter
- Reusable Standard Iso/Sevo Adapter
- Scavenging Tube
- Sedaconda ACD-L
- Sedaconda® ACD-S
- Sedconda Filling Adapter
- Single-Use Standard Iso/Sevo Adapter
Catalogue references include 1026045, 1026049, 1026063, 1026094, 1026096, 26042.
European nomenclature codes declared: R9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SEDANA MEDICAL LIMITED |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2014-01-14 |
Licence types: System (1).
Licensed under: SEDACONDA SYSTEM.
North American profile: Canada only. Sedana Medical Limited holds a Canadian licence but was not found in the U.S. register.