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Medtronic Minimed, Inc.

USA · Northridge

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

24listed device types

Class I 3Class II 14Class III 7

plus 57 registration records and 57 510(k), 581 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

11 including historic records

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 1Class III 4Class IV 2

48 including historic records

TWTaiwanTFDA

6valid device licences

Class II 2Class III 4

SGSingaporeHSA SMDR

10device registrations

CLASS B 3CLASS C 7

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

26active ARTG entries

Class I 9Class III 2IIa 3IIb 12

HKHong KongMDACS

7valid listings

Class II 3Class III 3Class IV 1

ILIsraelAMAR

22registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 1Class 2a 4Class 2b 5

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 States57 registration records, 57 510(k), 581 PMA, 1 excluded

Brazil5 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: MEDTRONIC MINIMED · Medtronic MiniMed

FDA 510(k) clearances by year

11994

31996

61997

11998

51999

12000

52003

42004

32005

12006

12007

12008

12010

12012

12015

12016

12022

22024

22025

62026

FDA listed device types

showing 8 of 24

Introducer, Syringe Needle 1Continuous Glucose Monitor Secondary Display 1Glucose Oxidase, Glucose 1Insulin Pump Secondary Display 1Pump, Infusion, Insulin 1Syringe, Piston 1Accessories, Pump, Infusion 1Pump, Infusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261962	SmartGuard Technology; Predictive Low Glucose Technology	2026-07-09
US	K253743	MiniMed Flex pump	2026-03-12
US	K253701	SmartGuard Technology; Predictive Low Glucose Technology	2026-02-03
BR	10349000612	MINIMED QUICK-SERTER	Class I
BR	10349000655	DISPOSITIVOS DE INSERÇÃO MINIMED	Class I
BR	10349000656	ONE-PRESS SERTER	Class II
SA	ME0000000248SFDAA00014	Sil-serter	—
SA	ME0000015320SFDAA00005	MiniMed Quick-Serter	—
CA	15138	MICROMED 407C INFUSION PUMP	Class III
CA	62859	PARADIGM INSULIN INFUSION PUMP	Class III
CA	76089	CGMS IPRO SYSTEM	Class III