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S-CATH¿

FDA Adverse Event
Malfunction ·MEDIPLUS LTD·Product code QGC·June 6, 2023

Suprapubic Catheter Accessories

FDA classification
FDA Class 1 ·Suprapubic Catheter Accessories

Hartalega NGC Sdn. Bhd.

Manufacturer
🇲🇾 Malaysia·10 Basic UDI-DIs·554 Devices·7 Importers

LGC Clinical Diagnostics, Inc.

Manufacturer
🇺🇸 United States·84 Basic UDI-DIs·84 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

LGC Clinical Diagnostics, Inc.

Manufacturer
🇺🇸 United States·133 Basic UDI-DIs·133 Devices·DEKRA Certification B.V.

GC TECHNOLOGY

Manufacturer
🇫🇷 France

GC MEDIS Corp.

Manufacturer
🇰🇷 South Korea·31 Basic UDI-DIs·31 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

GC Europe NV

Manufacturer
🇧🇪 Belgium

Nagor Limited

Manufacturer
240 Basic UDI-DIs·240 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

GC Medical Science Corporation

Manufacturer
🇰🇷 South Korea·11 Basic UDI-DIs·11 Devices·TÜV SÜD Product Service GmbH

GC Orthodontics Europe GmbH

Manufacturer
🇩🇪 Germany

GC Tech. Europe GmbH

Manufacturer
🇩🇪 Germany

AGC-HDC-1、AGC-HDC-2

Device
EU MDR · Eu Md Class 1 ·Wuzhou Aokace Technology Co., Ltd.·On the market

AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD

FDA 510(k)
FDA Class 2 ·Dental

AGC Glanzzusatz

Device
EU MDR · Eu Md Class 2a ·C.HAFNER GmbH + Co. KG·On the market·9 countries

magLEAD 4gC

Device
EU IVDR · Eu Ivd Class A ·Precision System Science Co., Ltd.·Not intended for eu market

HARTALEGA NGC SDN BHD

FDA registration
HARTALEGA NGC SDN BHD·7 products·🇲🇾 Malaysia

LGC Clinical Diagnostics, Inc.

FDA registration
LGC Clinical Diagnostics, Inc.·3 products·🇺🇸 United States

LGC Clinical Diagnostics, Inc.

FDA registration
LGC Clinical Diagnostics, Inc.·3 products·🇺🇸 United States

LGC Clinical Diagnostics, Inc.

FDA registration
LGC Clinical Diagnostics, Inc.·9 products·🇺🇸 United States