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Personal KinetiGraph (PKG) System

FDA registration
GKC MANUFACTURING PTY LTD·3 products·🇦🇺 Australia

Multichem MS ISDs Level 1

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Techno-path Manufacturing Ltd.·2 devices

Ultrasound Paper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·3 devices

Medical Chart Recording Paper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·133 devices

Medical Chart Recording Paper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·183 devices

Ultrasound Paper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·3 devices

Medical Chart Recording Paper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·285 devices

ECG Gel

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·2 devices

Ultrasound Transmission Medical Gel

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ISD MEDITECH SDN. BHD.·4 devices

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·CONTIGEN BARD COLLAGEN IMPLANT

Bioness Integrated Therapy System, BITS 3.0, BITS Balance

FDA UDI
BIONESS INC.·00815962020627·BITS PC Kit, BITS Balance Accessory Kit, and BI...

Biometrics Ltd Dynamometer

FDA UDI
BIOMETRICS LIMITED·05060481690027·The Biometrics Dynamometer utilises precision l...

E-LINK AD1 Wireless Adaptor

FDA UDI
BIOMETRICS LIMITED·05060481690218·The AD1 wireless Adaptor which can be used with...

BITS Motion Sensor

FDA UDI
BIONESS INC.·00815962020634·Bioness Integrated Therapy System Version 3.0 M...

Biometrics Ltd Dynamometer

FDA UDI
BIOMETRICS LIMITED·05060481692403·The Biometrics Dynamometer utilises precision l...

Biometrics Ltd Pinchmeter

FDA UDI
BIOMETRICS LIMITED·05060481692410·The unique electronic pinchmeter has a low prof...

Biometrics Ltd Pinchmeter

FDA UDI
BIOMETRICS LIMITED·05060481690034·The unique electronic pinchmeter has a low prof...

E-LINK CA1 Battery Charger

FDA UDI
BIOMETRICS LIMITED·05060481690201·Mains powered battery charging unit for up to 4...

Bioness Integrated Therapy System, BITS 3.0, BITS Balance

FDA UDI
BIONESS INC.·00815962020610·Bioness Integrated Therapy System Version 3.0, ...

E-LINK DG1 Wireless Dongle

FDA UDI
BIOMETRICS LIMITED·05060481690195·The wireless Dongle (DG1) enables E-LINK to be ...