DYSIS Medical LTD
UK-MF-000038215 · United Kingdom · Edinburgh
DYSIS Medical LTD is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: DYSIS Disposable Speculum, DYSIS Treatment pipe, DYSIS Ultra 3.0.
Among these devices, 4 are declared sterile, 2 active.
Authorised representative in the Union: DYSIS MEDICAL ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΣΜΟΥ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ.
Devices declared under this manufacturer
- DYSIS Disposable Speculum
- DYSIS Disposable Treatment Pipe
- DYSIS Ultra 3.0
- DYSIS View
Catalogue references include DSP001, DSP002, DSP003, DYS404, TRP001, VIE001.
European nomenclature codes declared: U089006, Z12020703, K02010107.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 16.7 % |
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. DYSIS Medical LTD was not found in either the U.S. or the Canadian register.