AUTOSET SPIRIT CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

VPAP ADAPT

FDA 510(k)

FDA Class 2 ·Anesthesiology

EasyCare Tx 2

FDA 510(k)

FDA Class 2 ·Anesthesiology

MIRAGE ECHO

FDA 510(k)

FDA Class 2 ·Anesthesiology

S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

S8 ASPEN WITH H4I PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

myAir

FDA 510(k)

FDA Class 2 ·Anesthesiology

Galapogos

FDA 510(k)

FDA Class 2 ·Anesthesiology

S9 ELOUERA

FDA 510(k)

FDA Class 2 ·Anesthesiology

myAir

FDA 510(k)

FDA Class 2 ·Anesthesiology

ResMed SAS

Authorized representative

🇫🇷 France·3 Manufacturers·1 Device

ResMed European Operations BV

Importer

🇳🇱 Netherlands·4 Manufacturers

Besmed Health Business Corp.

Manufacturer

🇹🇼 Taiwan·399 Basic UDI-DIs·475 Devices·3 Importers·DEKRA Certification B.V., DEKRA Certification B.V., and TÜV Rheinland LGA Products GmbH

Besmed Health Business Corp.

Manufacturer

🇹🇼 Taiwan

CLOSTRIDIUM DIFFICILE TOX-B TEST

FDA 510(k)

FDA Class 1 ·Microbiology

BESMED OXYGEN MASK

FDA registration

NINGBO BESMED MEDICAL EQUIPMENT CORP.·1 product·🇨🇳 China

Besmed CO2 Monitoring Line With and Without In-Line Filter

FDA registration

NINGBO BESMED MEDICAL EQUIPMENT CORP.·1 product·🇨🇳 China

BESMED HUMIDIFIER

FDA registration

NINGBO BESMED MEDICAL EQUIPMENT CORP.·1 product·🇨🇳 China

Besmed Tracheal Tube Stylet

FDA registration

BESMED HEALTH BUSINESS CORP.-Chiayi·1 product·🇹🇼 Taiwan