Minitube AB
SE-MF-000002089 · Sweden · Trångsviken
Minitube AB is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 29 |
|---|
Devices declared under this manufacturer
- Bluephase Schutzhüllen (G2)
- Bluephase Style Schutzhüllen
- DentaSleeve size 0
- DentaSleeve size XL
- Digisept Electro Lubrifié
- Digisept Electro Non Lubrifié
- OdneClean Sleeve
- THERMOSEPT
- TRIOS 5 Sleeve
- Tempasept
- Top Dent Sensorskydd
- Top Dent Sensorskydd Strl 1
Showing 12 of 29 declared devices.
Catalogue references include 402605, 403062, 403602, 403634, 403642, 436000.
European nomenclature codes declared: T030102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MINITUBE AB (SE) · FDA 8032009 |
| Devices in EUDAMED | 29 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 42.9 % |
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. Minitube AB is registered in the United States but was not found in the Canadian register.