Viomedex Ltd
GB-MF-000004399 · United Kingdom · Croydon
Viomedex Ltd is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 22 |
|---|
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- First Breath Headgear - Extra Large (XL) - Qty 1
- First Breath Headgear - Extra Large (XL) - Qty 10
- First Breath Headgear - Extra Small (XS) - Qty 10
- First Breath Headgear - Fixation Block - Qty 20
- First Breath Headgear - Large (L) - Qty 1
- First Breath Headgear - Large (L) - Qty 10
- First Breath Headgear - Medium (M) - Qty 1
- First Breath Headgear - Medium (M) - Qty 10
- Respiration Sensor - Aerogen Pharma - Qty 50
- Respiration Sensor - Lowenstein Medical - Qty 50
- Respiration Sensor - Lowenstein Medical - Qty1
- Respiration Sensor - Stephan - Qty 1
Showing 12 of 22 declared devices.
Catalogue references include 217116, VX015AER, VX8011/10, VX8013/10, VX8014, VX8015.
European nomenclature codes declared: R0301010401, Z12040185.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 22 |
| 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 | 22 |
|---|---|
| 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. Viomedex Ltd was not found in either the U.S. or the Canadian register.