DELBIO INC.

Manufacturer

🇹🇼 Taiwan·7 Basic UDI-DIs·14 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

FEELLIFE HEALTH INC.

Manufacturer

🇨🇳 China·16 Basic UDI-DIs·16 Devices·4 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Shenzhen Denco Medical Co., Ltd.

Manufacturer

🇨🇳 China·174 Basic UDI-DIs·174 Devices·4 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

MACHEREY-NAGEL GmbH & Co. KG

Manufacturer

🇩🇪 Germany·9 Basic UDI-DIs·14 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Fleming Medical Ltd.

Manufacturer

🇨🇳 China·36 Basic UDI-DIs·145 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Grena (Qingdao) Medical Devices Ltd.

Manufacturer

🇨🇳 China·247 Basic UDI-DIs·247 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Chengdu Rich Science Industry Co., Ltd.

Manufacturer

🇨🇳 China·6 Basic UDI-DIs·7 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Suzhou Zhenwu Medical Co., Ltd.

Manufacturer

🇨🇳 China·8 Basic UDI-DIs·8 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Messer France

Manufacturer

🇫🇷 France·11 Basic UDI-DIs·16 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Soft Sensor Medium WO2 Model 8000SM-WO2

FDA UDI

NONIN MEDICAL, INC.·00849686051001·Model 8000SM-WO2, Soft Sensor Medium WO2, Phili...

Soft Sensor Large WO2 Model 8000SL-WO2

FDA UDI

NONIN MEDICAL, INC.·00849686050998·Model 8000SL-WO2, Soft Sensor Large WO2, Philip...

Soft Sensor Small WO2 Model 8000SS-WO2

FDA UDI

NONIN MEDICAL, INC.·00849686051018·Model 8000SS-WO2, Soft Sensor Small WO2, Philip...

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN

Automated Nucleic Acid Extraction Instrument (EX3600)

FDA registration

SHANGHAI ZJ BIO-TECH CO., LTD.·1 product·🇨🇳 China

Viral RNA Isolation Kit (Preloaded for Auto-Extraction)

FDA registration

SHANGHAI ZJ BIO-TECH CO., LTD.·1 product·🇨🇳 China

ECG cable

FDA registration

SHENZHEN YKD TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

Underpad

FDA registration

ARRCARE MEDICAL TECHNOLOGY CO.,LTD.·1 product·🇨🇳 China

Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800)

FDA registration

SHANGHAI ZJ BIO-TECH CO., LTD.·1 product·🇨🇳 China

S57D DIGITAL OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 67D OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology