Data / Medical devices / Sweden / Minitube AB
Minitube AB: FDA-registered device maker in TRANGSVIKEN Jamtland, Sweden, 1 510(k) clearance
Minitube AB is registered with the FDA (registration 8032009) in TRANGSVIKEN Jamtland, Sweden. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8032009
- FEI number
- 3001697252
- Address
- Byvagen 44, TRANGSVIKEN Jamtland, Sweden, 835 96
- Owner or operator
- MINITUBE AB (8032009)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 12, 2011
- Registered through
- 2027
- Brand names listed
- BLUEPHASE, Barrier sleeves, Dentasleeve, Intraoral Camera Sheath, MEDLINE LUBRICATED THERMOMETER SHEATH, Medline thermometer sleeves, Minitube X-Ray Sensor Sheath, RINN® Large Digital Sensor Covers (Soft Overbag Cover) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2021 | K211026 | Minitube Dentasleeve Protective Barrier Sleeves | PEM | Substantially Equivalent | Minitube AB | accessdata.fda.gov |
Compare with other makers
- All makers of Dental Barriers And Sleeves
- All makers of Continuous Measurement Thermometer
- All makers of Unit, Operative Dental, Accessories
Updated August 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.