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Jiangsu Healthy Medical Equipment Co;Ltd

Taiwan · Hsin Chu City

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

18listed device types

Class I 17Class II 1Class III 0

plus 18 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

5registered 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

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 States18 registration records, 2 510(k), 0 PMA, 10 excluded

Brazil1 confirmed, 2 excluded

Saudi Arabia5 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: JIANGSU REAK HEALTHY ARTICLES CO.,LTD · JIANGSU REAK HEALTHY ARTICLES CO LTD · Jiangsu Medakor Healthy Articles Co., Ltd.

Same-named companies — This database also contains companies with near-identical names: Jiangsu Healthy Way Medical Equipment Co;Ltd, JIANGSU REAK HEALTHY ARTICLES CO.,LTD. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22012 · K112948

FDA listed device types

showing 8 of 18

Adaptor, Dressing 1Joint, Knee, External Brace 1Orthosis, Limb Brace 1Protector, Skin Pressure 1Orthosis, Abdominal 1Support, Patient Position 1Orthosis, Lumbar 1Orthosis, Truncal/Orthosis, Limb 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K112948	JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR	2012-03-28
US	K112950	JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR	2012-03-28
BR	10340440042	SUPORTE ELÁSTICO PARA MEMBROS E ARTICULACÕES	Class I
SA	ME0000013089SFDAA00001	Medakor	—
SA	ME0000013089SFDAA00002	Medakor	—

Jiangsu Healthy Medical Equipment 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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