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Micromate™ / Micromate™ Navi+

by iSYS Medizintechnik GmbH EUDAMED

Active European Union

Ref 48954Model iONE

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9010279MicromateH2 Basic UDI-DIDate20 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
iONE, 48954
Primary DI / UDI-DI
09010279000961
Basic UDI-DI
9010279MicromateH2
EMDN Code
Z12011401 Surgical navigation system
Device Class
Class I
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.

Manufacturer details

EUDAMED SRN
AT-PR-000003101

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Properties

Show properties
Other properties (1)
  • Sterile: No