601591

Organization name

Focal Meditech BV

SRN

NL-MF-000000536

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 5 countries total.

Trade name

not provided

UDI-DI code

08719327649480

Basic UDI-DI

87193276494FOCRI2QG

Reference / catalog number

601591

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Robot Interface consists of a liftarm, a control box and a battery power cable. The liftarm is controlled by the controlbox based on a user input device of a switch from Focal Meditech or a 3,5mm switch. The power for the Robot Interface is retrieved from the control box via a cable through the liftarm. In the liftarm there is also an extension cable for the data connector of the robotmanipulator. The joystick can be connected on this cable. The control box is available in two versions: a single switch version and a two switch version. In the single switch version the liftarm toggles between moving up and down when the button is pressed. In the two switch version there is a separate button for the upwards movement and one for moving downwards. The device stops automatically when the liftarm reaches the highest or lowest position or when the actuator draws too much current.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y240999CONTROL DEVICES AND SYSTEMS - OTHER