Planmeca Oy

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

7 non-EU manufacturers

• Abrasive Technology LLC 🇺🇸 US
• Bien-Air Dental SA 🇨🇭 CH
• DCI International, LLC 🇺🇸 US
• DENTALL Co., Ltd. 🇰🇷 KR
• DIGIRAY Corp. 🇰🇷 KR
• E.M.S. Electro Medical Systems S.A. 🇨🇭 CH
• J. MORITA MFG. CORP. 🇯🇵 JP

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