Eu Mdr Eu Md Class 1 On The Market 🇨🇳 China

4K Fluorescent Medical Endoscope Camera System

Devices (same UDI-DI)
4
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06976042830018
Basic UDI-DI Code
697604283SZ-FLCAMDU
Reference
SZ-FL9088
Device Types
Sterilization
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The product is mainly composed of camera controller, waterproof camera and optical interface. Used to connect with an optical endoscope during endoscopic diagnosis and/or treatment/surgery, to capture, process and transmit images of the field of view area of the body cavity observed by the endoscope to a monitor. Used in conjunction with the fluorescent contrast agent Indocyanine Green (ICG), it provides real-time visible and near-infrared fluorescence images during endoscopic diagnosis/surgery.

CND Nomenclature Codes

Code Description
Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES

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