Data / Medical devices / Netherlands / Tandem Diabetes Care Europe B.V.
Tandem Diabetes Care Europe B.V.: FDA-registered device maker in Schiphol Noord-Holland, Netherlands, 3 510(k) clearances
Tandem Diabetes Care Europe B.V. is registered with the FDA (registration 3026266833) in Schiphol Noord-Holland, Netherlands. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 15, 2022. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3026266833
- Address
- 359 Schiphol Boulevard, Schiphol Noord-Holland, Netherlands, 1118BJ
- Owner or operator
- Tandem Diabetes Care, Inc. (10039506)
- Roles
- Exporter to the US
- First device listed
- November 23, 2020
- Registered through
- 2027
- Brand names listed
- t:slim X2 with Basal-IQ technology, t:slim X2 with Control-IQ technology
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Exporter to the US | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller | QJI | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| February 15, 2022 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| June 16, 2020 | K200467 | Control-IQ Technology | QJI | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
| June 4, 2020 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | Tandem Diabetes Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Interoperable Automated Glycemic Controller
- All makers of Alternate Controller Enabled Insulin Infusion Pump
Updated February 15, 2022. 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.