Electrode Headset

FDA UDI

Brainscope Company, Inc.·00852745007062·

BrainScope One International Charging Kit

FDA UDI

Brainscope Company, Inc.·00852745007093·

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

ActiSleep+; GT3X+; GT9X; wActiSleep+; wGT3X+; wGT3X-BT;GT3X;CPIW;CPIW Dock;CPIW v2;CPIW V2 Dock;CDH;CDH-4G;GTX9R

FDA registration

Mirac, LLC·1 product·🇺🇸 United States

EIWE

FDA registration

Gyrus ACMI, Inc.·1 product·🇺🇸 United States

EIWE

FDA registration

GYRUS ACMI, INC.·1 product·🇺🇸 United States

Pik Pak Industries

Manufacturer

🇵🇰 Pakistan

PIE Co., Ltd.

Manufacturer

🇰🇷 South Korea

Water Pik, Inc.

Manufacturer

🇺🇸 United States·8 Basic UDI-DIs·81 Devices·1 Importer

Pie Medical Imaging B.V.

Manufacturer

🇳🇱 Netherlands·23 Basic UDI-DIs·23 Devices·TÜV SÜD Product Service GmbH

PIC (HK) LTD.

FDA registration

PIC (HK) LTD.·1 product·🇨🇳 China

PIC camera

FDA registration

IDITEC NORTH WEST S.L.·1 product·🇪🇸 Spain

PIC system, PIC system Gravity

FDA registration

IDITEC NORTH WEST S.L.·1 product·🇪🇸 Spain

PIC transfer

FDA registration

IDITEC NORTH WEST S.L.·1 product·🇪🇸 Spain

USA Elite

FDA UDI

Gyrus Acmi, Inc.·00821925001954·USA Elite System Iglesias Short Block Working E...

CAAS, CAASII, CAAS2000

FDA registration

PIE MEDICAL IMAGING B.V.·1 product·🇳🇱 Netherlands

CAAS MR Solutions

FDA registration

PIE MEDICAL IMAGING B.V.·1 product·🇳🇱 Netherlands

CAAS A-Valve 2

FDA registration

PIE MEDICAL IMAGING B.V.·1 product·🇳🇱 Netherlands

CAAS MR Solutions

FDA registration

PIE MEDICAL IMAGING B.V.·1 product·🇳🇱 Netherlands

Caas Qardia

FDA registration

PIE MEDICAL IMAGING B.V.·1 product·🇳🇱 Netherlands