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MERITS HEALTH PRODUCTS CO., LTD.

USA · Las Vegas

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, South Korea, Australia, Israel — 5 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

26listed device types

Class I 22Class II 4Class III 0

plus 79 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States79 registration records, 31 510(k), 0 PMA, 3 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: MERITS HEALTH PRODUCTS, INC. · MERITS HEALTH PRODUCTS CO., LTD. · MERITS HEALTH PRODUCTS., INC.

FDA 510(k) clearances by year

11993

11994

11996

11998

11999

12000

82001

12002

32005

42006

22008

22010

12012

12013

22015

12022

FDA listed device types

showing 8 of 26

Vehicle, Motorized 3-Wheeled 1Powered Stairway Chair Lift 1Wheelchair, Powered 1Lift, Patient, Ac-Powered 1Device, Anti-Tip, Wheelchair 1Armrest, Wheelchair 1Lift, Patient, Non-Ac-Powered 1Device, Transfer, Patient, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220529	Merits P335 Powered Wheelchair	2022-03-18
US	K142912	Merits Yoga Power Scooter, S542	2015-06-23
US	K142162	MERITS TRANSFORMER POWER SCOOTER, S941	2015-05-01
SA	ME0000007250SFDAA00001	Kompas	—

MERITS HEALTH PRODUCTS CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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