Oto Dr

Device Name

Implantable Pacemakers - OTO

Model / Reference

OTO DR, TPM018C

Primary DI / UDI-DI

08031527017228

Basic UDI-DI

B-08031527017228

EMDN Code

J01010302 Implantable dual chamber pacemakers with sensor (dr)

Device Class

Class AIMDD

Market of Registration

Italy

EUDAMED SRN

IT-MF-000029013

• Teo Sr

  Active implantable (AIMDD)

  CE/AIMDD

• RC031

  Class I

  CE/MDR

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  Class I

  CE/MDR

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  Class I

  CE/MDR

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  Active implantable (AIMDD)

  CE/AIMDD

• Navigo 4LV 2D 78/Arc 78 Re-Intervention Kit 78

  Class III

  CE/MDR G70 005178 0044 Active Valid to Dec 2031

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