HomeSingaporeMedtronic Singapore Operations Pte Ltd

Medtronic Singapore Operations Pte Ltd

Singapore · Singapore Central Singapore
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 3 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
18listed device types
Class I 4Class II 6Class III 7unclassified 1
plus 20 registration records and 0 510(k)
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
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
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 States20 registration records, 0 510(k), 0 PMA, 30 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 9 excluded
Manufacturer names merged into this page: Medtronic Singapore Operations Pte Ltd · Vela Operations Singapore Pte Ltd

Company information

Country
Singapore
City
Singapore Central Singapore

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 listed device types

showing 8 of 18
Detector And Alarm, Arrhythmia 1Real Time Nucleic Acid Amplification System 1Herpes Simplex Virus Nucleic Acid Amplification Assay 1High Throughput Dna Sequence Analyzer 1Hiv-1 Genotyping Assay Using Ngs Technology 1Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) 1Permanent Pacemaker Electrode 1Implantable Pacemaker Pulse-Generator 1

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