Novista of Sweden AB
SE-MF-000045071 · Sweden · Skummeslövsstrand
Novista of Sweden AB is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 61 |
|---|
Most frequent device types declared: Fiber Futon Stella, Hygiene Cover Ecoverde, Weight Duvet Futura, Weight Duvet Nova, Weight Duvet Safir.
Among these devices, 15 are declared active.
Devices declared under this manufacturer
- Futura 140 10 kg
- Futura 2.3 kg
- Hygiene Cover Ecoverde 150x200 cm
- Nova 100x140 2.3 kg
- Nova 12 kg
- Nova 8 kg
- Safir 10 kg
- Safir 2.3 kg
- Safir 3.7 kg
- Stella 5 kg
- Weight Vest 122-128 cl
- Weight Vest 134-142 cl
Showing 12 of 61 declared devices.
Catalogue references include 07350081311407, 735008131C6R, 735008131F6X, 735008131HCPZ, 735008131N7F, 735008131SAQW.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 61 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 61 |
|---|---|
| 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. Novista of Sweden AB was not found in either the U.S. or the Canadian register.