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Merit Medical Singapore Pte. , Ltd.

Singapore · Singapore

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

12listed device types

Class I 0Class II 12Class III 0

plus 13 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

23active device licences

Class II 17Class III 3Class IV 3

44 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

22device registrations

CLASS B 18CLASS D 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 2IIa 5

HKHong KongMDACS

5valid listings

Class II 3Class IV 2

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 1Class 3 2

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 States13 registration records, 2 510(k), 0 PMA, 21 excluded

Brazil2 confirmed, 7 excluded

Canada23 confirmed, 3 excluded

Manufacturer names merged into this page: Merit Medical Singapore Pte. Ltd. · MERIT MEDICAL SINGAPORE PTE. LTD. · MERIT MEDICAL SINGAPORE PTE. LTD

FDA 510(k) clearances by year

12019 · K182538

12023 · K221782

FDA listed device types

showing 8 of 12

Catheter, Continuous Flush 1Transducer, Blood-Pressure, Extravascular 1Stopcock, I.V. Set 1Computer, Diagnostic, Pre-Programmed, Single-Function 1System, Measurement, Blood-Pressure, Non-Invasive 1Catheter, Intravascular, Diagnostic 1Computer, Blood-Pressure 1Intravenous Extension Tubing Set 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221782	Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes	2023-03-17
US	K182538	Merit RadialFlo Arterial Catheter	2019-01-16
BR	80740950128	Cabo de Interface para Transdutor Merit	Class I
BR	80740950151	Cateter Arterial Careflow	Class II
CA	3237	HYDROCATH CENTRAL VENOUS CATHETER	Class II
CA	5996	PERCENTANEOUS SHEATH INTRODUCER KIT (BASIC)	Class II
CA	9407	GUIDEWIRE	Class II