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SAFECARE BIOTECH (HANGZHOU) CO., LTD.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·2 Importers

ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

FDA registration
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.·7 products·🇨🇳 China

Arc Manufacturing, Inc. (Tie San Jiao)

FDA registration
Arc Manufacturing, Inc. (Tie San Jiao)·1 product·🇨🇳 China

Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer
🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

Safecare THC Rapid Test Panel (Saliva)

Device
EU IVDD · Eu Ivd General ·SAFECARE BIOTECH (HANGZHOU) CO., LTD.·On the market

NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Enforcement
Class II ·Terminated·Neusoft Medical Systems Co., Ltd.·May 29, 2019

NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Enforcement
Class II ·Terminated·Neusoft Medical Systems Co., Ltd.·May 29, 2019

OPTICAL LABORATORY MICROSCOPES

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

OPTICAL LABORATORY MICROSCOPES

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

OPTICAL LABORATORY MICROSCOPES

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)

Device
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method)

Device
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method)

Device
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

Disposable Virus Sampling Tube

Device
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market