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Hsiner Co., LTD

Taiwan · Taichung City · www.hsiner.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN TW-MF-000007258

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Israel, Russia — 11 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

89UDI-DI device records

Class I 5Class IIa 83Class III 1

USUnited StatesFDA openFDA

26listed device types

Class I 19Class II 7Class III 0

plus 58 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 5Class IIa 7

BRBrazilANVISA

55registered devices

Class I 4Class II 51

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

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

24active ARTG entries

Class I 1IIa 14IIb 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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.

European Union89 raw hits, 0 excluded, 89 confirmed

United States58 registration records, 9 510(k), 0 PMA

United Kingdom12 confirmed, 0 excluded

Brazil55 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: HSINER CO., LTD. · HSINER CO. LTD. · HSINER, INC · Hsiner CO.,Ltd.

Regulatory identity

EU manufacturer SRN: TW-MF-000007258
EU authorised representative: mdi Europa GmbH
UK responsible person: Qserve Group UK, Ltd.

FDA 510(k) clearances by year

12005

12006

22007

12008

12009

12011

12012

12026

FDA listed device types

showing 8 of 26

Filter, Bacterial, Breathing-Circuit 1Ventilator, Non-Continuous (Respirator) 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Nebulizer (Direct Patient Interface) 1Attachment, Breathing, Positive End Expiratory Pressure 1Ventilator, Emergency, Manual (Resuscitator) 1Ventilator, Continuous, Facility Use 1Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719964250821	—	Class IIa
EU	04719964250814	—	Class IIa
EU	04719964250807	—	Class IIa
EU	04719964250708	—	Class IIa
UK	46232	Disposable Air Cushion Mask: Size #3-Child	Class IIa
UK	31254	Black Headgear	Class I
UK	57814	"Total Full Face CPAP Mask (For Pediatric), size S	Class IIa
US	K251888	VPAP Pediatric Face Mask	2026-03-12
US	K120920	HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA	2012-07-16
US	K102120	NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202	2011-08-12
BR	10273829009	RESSUCITADOR MANUAL	Class II
BR	80171530090	Máscara Venturi Ajustável	Class II
BR	80171530012	Máscara Laríngea Newmed	Class II
SA	ME0000007422SFDAA00021	BREATHING CIRCUIT SYSTEM REUSABLE	—
SA	ME0000007421SFDAA00026	Water Bag	—