Eu Mdr Eu Md Class 1 On The Market

Micromate™ / Micromate™ Navi+

The Micromate is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of a needle or electrode where optical navigation, computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intra-operative tracking. The needle or electrode is then manually advanced by the user. Trajectory planning is made with software that is a part of Micromate™ device or any external compatible station.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
09010279000961
Basic UDI-DI Code
9010279MicromateH2
Reference
48954
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The iONE Micromate™ Navi + is a system according to the Medical Device Regulation (MDR) Article 22, and contains all the components and accessories that belong to the iONE / Micromate™.

Medical Purpose

The Micromate is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of a needle or electrode where optical navigation, computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intra-operative tracking. The needle or electrode is then manually advanced by the user. Trajectory planning is made with software that is a part of Micromate™ device or any external compatible station.

CND Nomenclature Codes

Code Description
Z12011401 SURGICAL NAVIGATION SYSTEM

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