New Wellness Concept
ES-MF-000041771 · Spain · Sevilla
New Wellness Concept is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 10 |
|---|
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- HORIXON 3-RING PACK
- HORIXON CONTROL
- HORIXON RING FIRM
- HORIXON RING INTENSE
- HORIXON RING LIGHT
- MYHIXEL 3-RING PACK
- MYHIXEL CONTROL
- MYHIXEL RING FIRM
- MYHIXEL RING INTENSE
- MYHIXEL RING LIGHT
Catalogue references include HXN_PA_0001, HXN_PA_0002, HXN_PA_0003, HXN_PA_0006, MHX_PA_0008, MHX_PA_0009.
European nomenclature codes declared: Z12169004, Z12169082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NEW WELLNESS CONCEPT SL (ES) · FDA 3017552081 |
| Devices in EUDAMED | 10 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| 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: United States only. New Wellness Concept is registered in the United States but was not found in the Canadian register.