FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

STRETCHER TRANSIT ISOLATER #122

FDA 510(k)

FDA Class 2 ·General Hospital

Carecube Negative Pressure Isolation Chamber

FDA 510(k)

FDA Class 2 ·General Hospital

ANAGO ISOLATION MASK (#80-950)

FDA 510(k)

FDA Class 2 ·General Hospital

SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE

FDA 510(k)

FDA Class 2 ·General Hospital

ORCA (tm) - Operational Rescue Containment Apparatus

FDA 510(k)

FDA Class 2 ·General Hospital

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM TEST SYSTEM

HAV lgM Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beijing Jinwofu Bioengineering Technology Co., Ltd.·1 device

Tigsun TORCH lgM Rapid Test

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

Tigsun TORCH lgM/lgG Rapid Test

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

Tigsun COVID-19 Combo lgM/lgG Rapid Test

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

Chamber, Patient Isolation

FDA classification

FDA Class 2 ·Chamber, Patient Isolation

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

AGM orthopaedics

Manufacturer

🇱🇻 Latvia·2 Basic UDI-DIs·55 Devices

Hangzhou Yinuowei Technology Co., Ltd

Manufacturer

🇨🇳 China

CGM TELEMEDICINE S.R.L.

Manufacturer

🇮🇹 Italy

CGM Clinical Europe GmbH

Manufacturer

🇩🇪 Germany·2 Basic UDI-DIs·2 Devices

NUCLEAR FAST RED 5GM

FDA registration

EMD MILLIPORE CORPORATION·1 product·🇺🇸 United States

NUCLEAR FAST RED 5GM

FDA registration

SIGMA-ALDRICH CORP.·1 product·🇺🇸 United States

NUCLEAR FAST RED 5GM

FDA registration

SIGMA-ALDRICH MANUFACTURING, LLC-H&H·1 product·🇺🇸 United States