Colchones Delax SL
ES-MF-000046525 · Spain · L´Alcudia
Colchones Delax SL is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 34 |
|---|
Most frequent device types declared: BABYKEEPER Therm 50x80, Babykeeper.
Devices declared under this manufacturer
- BABYKEEPER PROBIOTIC 57x117
- BABYKEEPER PROBIOTIC 60x120
- BABYKEEPER PROBIOTIC 70X140 OPTIMUS
- BABYKEEPER PROBIOTIC 70x140
- BABYKEEPER PROBIOTIC OPTIMUS 57X117
- BABYKEEPER TERNUM 60x120
- BABYKEEPER TERNUM 60x120 OPTIMUS
- BABYKEEPER TERNUM 70x140 OPTIMUS
- BABYKEEPER THERM 50x80
- BABYKEEPER THERM 60X120 OPTIMUS
- BABYKEEPER THERM 60x120
- funda auxiliar BABYKEEPER TERNUM 50x80
Showing 12 of 34 declared devices.
Catalogue references include 1234567.
European nomenclature codes declared: V028099, V080702.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 34 |
|---|---|
| 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. Colchones Delax SL was not found in either the U.S. or the Canadian register.