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Besmed Health Business Corp.

Taiwan · New Taipei City · www.besmed.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN TW-MF-000007246

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Singapore, Australia, Hong Kong, Israel, Russia — 10 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 50Class IIa 250

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

48listed device types

Class I 35Class II 13Class III 0

plus 55 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

34registered device records

Class I 6Class IIa 28

BRBrazilANVISA

97registered devices

Class I 26Class II 71

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

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

40active ARTG entries

Class I 7IIa 32IIb 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 Union571 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States55 registration records, 11 510(k), 0 PMA, 1 excluded

United Kingdom34 confirmed, 0 excluded

Brazil97 confirmed, 1 excluded

Saudi Arabia16 confirmed, 0 excluded

Manufacturer names merged into this page: Besmed Health Business Corporation · BESMED HEALTH BUSINESS CORP.-Chiayi · BESMED HEALTH BUSINESS CORP. · BESMED HEALTH BUSINESS CORP · Besmed health business cooperation · Besmed Health Business Corp.

Regulatory identity

EU manufacturer SRN: TW-MF-000007246
EU authorised representative: Casus Europe B.V.
UK responsible person: Qserve Group UK, Ltd.

FDA 510(k) clearances by year

22003

12009

32014

22015

12016

12018

12024

FDA listed device types

showing 8 of 48

Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Regulator, Pressure, Gas Cylinder 1Airway, Nasopharyngeal 1Mask, Gas, Anesthetic 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Catheter, Continuous Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-MP-791086E	Mouth Piece (OD: 22mm)	Class IIa
EU	D-SM-8614283	Silicone Mask, Size 4, Adult	Class IIa
EU	D-PO-8524076	Adapter for Humidifier	Class IIa
EU	D-CT-10018WE	SILICONE TUBE ID=22mm, L=180cm W/CONNECTOR	Class IIa
UK	35172	AEROSOL MASK	Class IIa
UK	37021	Anesthesia circuit,accessories	Class IIa
UK	60882	Head harness	Class I
US	K241339	Besmed Bacterial Filter and HMEF	2024-11-14
US	K172804	Besmed Peak Flow Meter	2018-01-11
US	K160112	Besmed PEEP Valve	2016-04-29
BR	10349590059	BESMED, MÁSCARA DE OXIGÊNIO	Class II
BR	80269339011	dreno de silicone com trocarte	Class II
BR	80269339012	Dreno de silicone sem trocarte	Class II
SA	ME0000006253SFDAA00101	Interface of nasal CPAP	—
SA	ME0000006253SFDAA00087	Besmed Nasal Oxygen Cannula; Nasal Prong; NCPAP Nasal Cannula	—

Besmed Health Business Corp.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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