Pjama AB
SE-MF-000016973 · Sweden · Skurup
Pjama AB is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 78 |
|---|
Among these devices, 37 are declared active.
Devices declared under this manufacturer
- DryGuardians
- Pjama
Showing 12 of 78 declared devices.
Catalogue references include 2004 Pjama Bedwetting Pants Blue Age 5-6 - 110/116, 2007 Pjama Bedwetting Pants Blue Age 6-8 - 122/128, 2010 Pjama Bedwetting Pants Blue Age 8 - 10 - 134/140, 2020 Pjama Bedwetting Shorts Blue Age 3-4 - 98/104, 2033, 9016.
European nomenclature codes declared: T0499, U070299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 78 |
| 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 | 78 |
|---|---|
| Found in the U.S. device database | 77 |
| Share | 98.7 % |
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. Pjama AB was not found in either the U.S. or the Canadian register.