SIT Swedish Implant Technology AB
SE-MF-000046935 · Sweden · Göteborg
SIT Swedish Implant Technology AB is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 35 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: 530000, 533503, 543500, 553501, 563538-31.
Among these devices, 15 are declared sterile, 26 implantable, 5 reusable, 2 with a measuring function.
Devices declared under this manufacturer
- Healing abutment Plus abutment
- Healing abutment ø4.8 x 3 mm
- Implant impression coping
- Plus abutment 2.5 mm
- Plus abutment 3.5 mm
- Prostetic screw Plus abutment
- Round bur
- Scan Body implant
- Screw tap ø3.5 mm
- Screwdriver
- TBL Implant ø5.0 x 10.6 mm
- TBL Implant ø5.0 x 12.1 mm
Showing 12 of 41 declared devices.
Catalogue references include 530000, 543500, 553501, 563538-31, 563539-2, 570030.
European nomenclature codes declared: P01020101, L15900899,Q010399, Q010399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 41 |
| 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 | 41 |
|---|---|
| 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. SIT Swedish Implant Technology AB was not found in either the U.S. or the Canadian register.