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Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

FDA Enforcement
Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

Prima OPH - Cataract Microscope

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Labotech Microscopes India Pvt. Ltd.·2 devices

Prima C/CS Colposcope

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Labotech Microscopes India Pvt. Ltd.·3 devices

PRIMA GN Colposcope

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Labotech Microscopes India Pvt. Ltd.·2 devices

Prima ENT - ENT Microscope

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Labotech Microscopes India Pvt. Ltd.·4 devices

Prima DNT(trainer) Table mount

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Labotech Microscopes India Pvt. Ltd.·1 device

Prima DNT - Dental Microscope Mobile mount

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Labotech Microscopes India Pvt. Ltd.·11 devices

EON MEDITECH PVT. LTD.

System producer
🇮🇳 India

2024-MDR/TD-031

Certificate
MDR Technical Documentation·Chetan Meditech Pvt. Ltd.·3EC International a.s.·1 Basic UDI-DI

2021-MDD/QS-021

Certificate
MDD Annex II (excluding section 4)·Chetan Meditech Pvt. Ltd.·3EC International a.s.·1 Basic UDI-DI