DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Primary DI

D-0302680UX

Basic UDI-DI Code

B-0302680UX

Reference

0302680

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

FRANKA EMIKA GmbH

SR-NOCS is a device for automatic naso- and oropharyngeal swabs as performed for diagnosis of highly infectious diseases like COVID-19. The goal is to minimize the contact between healthcare workers (HCWs) and patients. The system consists of the following components: 1. Franka Emika robot system, consisting of robot arm, control and hand (gripper), emergency stop. 2. Disposable cover for robot arm 3. Smear stick for actual test 4. Disposable positioning mask to help the patient in self-positioning, changed by the robot between tests 5. Robot gripper fingers to handle smear stick and positioning mask 6. Safety electronics to guarantee safe robot operation 7. Robot cell, consisting of multiple sub modules: a. Structure with robot mount, acrylic glass walls and perforated side shielding b. Positioning mask frame with locking mechanism c. Patient control pedals d. Operator control pedal e. Station status indicator f. Process status indicator g. Slide for positioning plate feed h. Electronic unit i. Disinfectant bath for gripper fingers j. Waste container k. Operator tray for testing equipment

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).