ORTHO KM
SE-MF-000044308 · Sweden · LUND
ORTHO KM is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: KMScreen SDL FULL.
Devices declared under this manufacturer
- KMScreen DICOM FULL
- KMScreen DICOM PC
- KMScreen DICOM SOFTWARE PLUS
- KMScreen SDL FULL
- KMScreen SDL PC
- KMScreen SDL SOFTWARE PLUS
Catalogue references include KMScreen DICOM FULL, KMScreen DICOM PC, KMScreen DICOM SOFTWARE PLUS, KMScreen SDL FULL, KMScreen SDL PC, KMScreen SDL SOFTWARE PLUS.
European nomenclature codes declared: Z1212012004.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. ORTHO KM was not found in either the U.S. or the Canadian register.