Eu Mdr Eu Md Class 1 Not Intended For Eu Market 🇦🇹 Austria

RoboticScope

BHS Technologies GmbH · 🇦🇹 Austria
Devices (same UDI-DI)
7
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
+B8581023120
Basic UDI-DI Code
++B858RoboticScope00000JE
Reference
102312
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
Not Intended For Eu Market
Manufacturer
BHS Technologies GmbH

Additional Description

The RoboticScope is an active class I medical device used for digital, surgical microscopy. The RoboticScope is intended to be used for illumination and enlarged visualization of the surgical area. Two cameras within the microscope head produce images of the surgical field and transmit them in real time to a Head-Mounted Display (HMD). The HMD in return is capable to detect the head-movements of the wearer and to translated them into movement commands for the robot or into commands for other key functions of the system (i.e. magnification level), enabling hands-free scope-control while maintaining an ergonomic pleasant posture of the user during the procedure.

CND Nomenclature Codes

Code Description
Z12011101 OPERATIVE MICROSCOPES

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