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Headstar Medical Products Co., Ltd.

Taiwan · New Taipei · www.headstarmedical.com

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Israel — 6 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

25listed device types

Class I 22Class II 3Class III 0

plus 26 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States26 registration records, 2 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: HEADSTAR MEDICAL PRODUCTS CO., LTD · HEADSTAR MEDICAL PRODUCTS CO., LTD. · HEADSTAR MEDICAL PRODUCTS CO.,LTD.

FDA 510(k) clearances by year

12001 · K002846

12013 · K121770

FDA listed device types

showing 8 of 25

Valve, Non-Rebreathing 1Ventilator, Emergency, Manual (Resuscitator) 1Nebulizer (Direct Patient Interface) 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Regulator, Pressure, Gas Cylinder 1Splint, Hand, And Components 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121770	HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER	2013-04-17
US	K002846	HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR	2001-06-06
BR	80070210031	Cânula Orofaríngea MD	Class I
BR	80070210038	MÁSCARA FACIAL COM COXIM INFLÁVEL - MD	Class I
BR	80070219031	MÁSCARA VENTURI MD	Class II

Headstar Medical Products 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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