Integrum AB
SE-MF-000026900 · Sweden · Mölndal
Integrum AB is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 42 |
|---|
Among these devices, 1 are declared sterile, 17 reusable.
Devices declared under this manufacturer
- Abutment Support E/F
- Fixture Removal Trephine and Guide Sleeves Kit 16 mm
- Fixture Removal Trephine and Guide Sleeves Kit 20 mm
- Fixture Removal Trephine and Guide Sleeves Kit 25 mm
- Humerus Training Kit
- Instrument Kit: Abutment Extraction G
- Instrument Kit: Fixture Removal G
- Instrument Kit: Fractured Abutment F/G
- Instrument Kit: Fractured Abutment Screw
- Instrument Kit: Measuring Straight 11.00- 11.50 F
- Instrument Kit: S1 & S2 Platform A/ B
- Instrument Kit: S1 Platform E/ F/ G
Showing 12 of 42 declared devices.
Catalogue references include 1475, 1596, 1636, 1736, 2536, 2549.
European nomenclature codes declared: L0399, V0199, Y0699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INTEGRUM AB (SE) · FDA 3011386779 |
| Devices in EUDAMED | 42 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 42 |
|---|---|
| Found in the U.S. device database | 25 |
| Share | 59.5 % |
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. Integrum AB is registered in the United States but was not found in the Canadian register.