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Chang Gung Medical Technology Co., Ltd.

Taiwan · Taipei City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia, Russia — 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

pendingnot queried

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

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 Supplies & Equipment Corp., 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 Technology 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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