Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026266833

FEI Number

3026266833

Entity Name

Tandem Diabetes Care Europe B.V.

City/State/Country

Schiphol Noord-Holland, NL

Establishment Address

359 Schiphol Boulevard, Schiphol Noord-Holland 1118BJ, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Tandem Diabetes Care, Inc. (Owner Number: 10039506)

Owner / Operator Contact Address

12400 High Bluff Drive, San Diego, CA 92130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200467

PMA Number

N/A

All Registered Proprietary Names

t:slim X2 with Basal-IQ technology t:slim X2 with Control-IQ technology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2022-04-14
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2020-11-23
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2020-11-23

Official Correspondent

Mark Tarby

US Agent Details

Mark Tarby Business: TANDEM DIABETES CARE, INC. Email: mtarby@tandemdiabetes.com Phone: (858) 2246319

Related Public Records

Same Entity

Tandem Diabetes Care, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027327302	TANDEM DIABETES CARE, INC.	Irvine, CA, US
3013756811	Tandem Diabetes Care, INC.	San Diego, CA, US
3032746481	TANDEM DIABETES CARE, INC.	San Diego, CA, US
3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US
3016540876	TANDEM DIABETES CARE, INC.	San Diego, CA, US

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3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026266833. Last updated year: 2026. Please use registration number 3026266833 when referencing this establishment in official correspondence.