Planmeca Oy

Devices placed in 32 countries

• Austria38
• Belgium38
• Bulgaria38
• Cyprus38
• Germany38
• Denmark38
• Estonia38
• Spain38
• Finland38
• France38
• Greece38
• Croatia38
• Hungary38
• Ireland38
• Iceland38
• Italy38
• Liechtenstein38
• Lithuania38
• Luxembourg38
• Latvia38
• Malta38
• Netherlands38
• Norway38
• Poland38
• Portugal38
• Romania38
• Sweden38
• Slovenia38
• Slovakia38
• Türkiye38
• XI38
• Czechia37

• Finnish Medicines Agency, Supervision and licences, Medical Device Unit
  FinlandContact the authority →

10 contacts identified

• JT
  JURVANEN Tuomas

  PRRC
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• KJ
  KANERVA Jukka

  PRRC
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• MT
  MULLER Timo

  PRRC
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• PH
  PUHLIN-NURMINEN Helianna

  PRRC
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• VN
  VUORIKALLAS Niina

  PRRC
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• VUORIKALLAS Niina
  - Quality management system - EU declaration of conformity - Vigilance reporting
  Hidden
• KANERVA Jukka
  CAD/CAM devices: - conformity of devices - technical documentation - post market surveillance - reporting obligations related to vigilance - conformity of investigational devices Custom-made devices: Promodel service - Overall responsibility (not shared)
  Hidden
• PUHLIN-NURMINEN Helianna
  Digital devices (software as a medical device): - conformity of devices - technical documentation - post market surveillance - reporting obligations related to vigilance - conformity of investigational devices
  Hidden
• MULLER Timo
  Dental x-ray devices: - conformity of devices - technical documentation - post market surveillance - reporting obligations related to vigilance - conformity of investigational devices
  Hidden
• JURVANEN Tuomas
  Dental units: - conformity of devices - technical documentation - post market surveillance - reporting obligations related to vigilance - conformity of investigational devices
  Hidden

• Planmeca Oy — FI-IM-000016566
• Planmeca Oy — FI-MF-000006499
• SGS FIMKO OY — 2 certificates — Planmeca Oy
• JURVANEN Tuomas — Planmeca Oy
• KANERVA Jukka — Planmeca Oy
• MULLER Timo — Planmeca Oy
• PUHLIN-NURMINEN Helianna — Planmeca Oy
• VUORIKALLAS Niina — Planmeca Oy