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Chilecom Medical Devices Co., Ltd.

China · Xiangtan Hunan

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 4Class II 1Class III 0

plus 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

SASaudi ArabiaSFDA

0registered 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, 1 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: CHILECOM MEDICAL DEVICES CO LTD · Chilecom Medical Devices Co. Ltd.

FDA 510(k) clearances by year

12009 · K080105

FDA listed device types

Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Stylet, Tracheal Tube 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1Pump, Nebulizer, Electrically Powered 1Tube, Tracheal (W/Wo Connector) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K080105	ENDOTRACHEAL TUBE	2009-02-13
BR	80292900086	TUBO ENDOBRONQUEAL DESCARTÁVEL EXELLENT	Class II
BR	80292900084	Tubo Endotraqueal Descartável Exellent Com Cuff	Class I
BR	80292900087	Tubo Endotraqueal Descartável Exellent Sem Cuff	Class II

Chilecom Medical Devices 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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