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Home›Netherlands›Tandem Diabetes Care Europe B.V.

Tandem Diabetes Care Europe B.V.

Netherlands · Schiphol Noord-Holland
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
15listed device types
Class I 2Class II 9Class III 4
plus 72 registration records and 26 510(k), 37 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States72 registration records, 26 510(k), 37 PMA, 2 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: TANDEM DIABETES CARE, INC. · Tandem Diabetes Care, INC. · Tandem Diabetes Care Europe B.V.
Same-named companies — This database also contains companies with near-identical names: TANDEM DIABETES CARE, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Schiphol Noord-Holland

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12011
12013
22014
12015
32016
22019
32020
12022
42023
22024
52025
12026

FDA listed device types

showing 8 of 15
Continuous Glucose Monitor Secondary Display 1Insulin Pump Secondary Display 1Pump, Infusion, Insulin 1Accessories, Pump, Infusion 1Alternate Controller Enabled Insulin Infusion Pump 1Set, Administration, Intravascular 1Calculator, Drug Dose 1Interoperable Automated Glycemic Controller 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260429Control-IQ+ technology2026-04-24
USK253074Tandem Mobi insulin pump with interoperable technology2025-11-06
USK250792t:slim X2 insulin pump with interoperable technology2025-09-24
CA100992T:SLIM X2 INSULIN PUMPClass III

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