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Chang Gung Medical Supplies & Equipment Corp.

USA · Dublin

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 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

5listed device types

Class I 2Class II 3Class III 0

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

10registered 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 States5 registration records, 4 510(k), 0 PMA

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: Chang Gung Medical Technology Co., Ltd. (Linkou Factory) · Chang Gung Medical Technology Co Ltd

Same-named companies — This database also contains companies with near-identical names: Chang Gung Medical Technology Co., Ltd., Chang Gung Medical Technology Co., Ltd. (Linkou Factory). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12009 · K090229

12010 · K102989

22015 · K142982

FDA listed device types

Bed, Pediatric Open Hospital 1Stretcher, Wheeled 1Bed, Ac-Powered Adjustable Hospital 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Apparatus, Traction, Non-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142982	OPUS 5100 Diagnostic Doppler Ultrasound System	2015-09-03
US	K142751	Chang Gung ComMed Series Dental Implant System	2015-06-15
US	K102989	OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS	2010-12-09
SA	ME0000009998SFDAA00002	Alternating Pressue Air Flotation Mattress	—
SA	ME0000009998SFDAA00003	Manual Pediatric Bed	—

Chang Gung Medical Supplies & Equipment Corp.

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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