102313

Organization name

BHS Technologies GmbH

SRN

AT-MF-000000309

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW261

  Risk group 2: CAUTION: Possibly hazardous optical radiation emitted from this product. Do not stare at operating lamp. May be harmful to the eye.
• CW011

  The RoboticScope must not be used for ophthalmological procedures/surgical processes/operations.
• CW259

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 10 countries total.

Trade name

not provided

UDI-DI code

+B8581023130

Basic UDI-DI

++B858RoboticScope00000JE

Reference / catalog number

102313

Issuing entity

HIBCC

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12011101OPERATIVE MICROSCOPES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification