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Kao Chen Enterprise Co., Ltd.

Taiwan · Taichung City · www.kaochen.com

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia — 4 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

0UDI-DI device records

USUnited StatesFDA openFDA

11listed device types

Class I 10Class II 0Class III 0unclassified 1

plus 11 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

26registered 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

2active ARTG entries

Class I 2

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.

European Union20,819 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States11 registration records, 0 510(k), 0 PMA, 3 excluded

United Kingdom0 confirmed, 42 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia26 confirmed, 0 excluded

Manufacturer names merged into this page: KAO CHEN ENTERPRISE CO., LTD. · KAO CHEN ENTERPRISE CO, LTDA · KAO CHEN ENTERPRISE CO., LTD · KAO CHEN ENTERPRISE CO. LTD. · KAO CHEN ENTERPRISES CO.LTD. · KAO CHEN ENTERPRISE CO

FDA listed device types

showing 8 of 11

Sling, Arm, Overhead Supported 1Joint, Shoulder, External Limb Component 1Joint, Knee, External Brace 1Orthosis, Lumbar 1Accessory, Surgical Apparel 1Splint, Hand, And Components 1Orthosis, Cervical 1Orthosis, Thoracic 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80676130009	BOLSA TÉRMICA ENDURANCE	Class I
BR	80018110096	FAMÍLIA DE ÓRTESES EXTERNAS PARA CERVICAL E TRONCO SOFTGUARDS	Class I
BR	80018110100	FAMÍLIA DE ÓRTESES EXTERNAS PARA MEMBROS INFERIORES SOFTGUARDS	Class I
SA	ME0000008579SFDAA00001	TRI-PANEL KNEE SPLINT	—
SA	ME0000008579SFDAA00003	HIP SPLINTS	—

Kao Chen Enterprise Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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