Ortoma AB
SE-MF-000034945 · Sweden · Gothenburg
Ortoma AB is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|---|
| Class IIb | 1 |
Among these devices, 4 are declared sterile, 16 reusable, 5 active, 2 with a measuring function.
Devices declared under this manufacturer
- OTS™ Aufsatzadapter Fix OT
- OTS™ Aufsatzadapter Twin OT
- OTS™ Computer- und Kameraständer
- OTS™ Einführinstrument-Adapter OTD
- OTS™ Gewindestifteindreher
- OTS™ Hüftplan
- OTS™ Kalibrieradaptereinheit OTD Emphasys
- OTS™ Mandrin und Pin
- OTS™ Messschraube 15 mm
- OTS™ Messschraube 8 mm
- OTS™ Pointer
- OTS™ Tracer CB
Showing 12 of 25 declared devices.
Catalogue references include 30-117, 30-142, 30-152, 30-155, 30-204, 60-001.
European nomenclature codes declared: Z12011401, Z12139092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORTOMA AB (SE) · FDA 3014411622 |
| Devices in EUDAMED | 25 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 25 |
|---|---|
| Found in the U.S. device database | 19 |
| Share | 76.0 % |
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. Ortoma AB is registered in the United States but was not found in the Canadian register.