Actim Oy

FDA Filings

This page includes the latest FDA filings for Actim Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013143953
• FEI Number: 3013143953
• Name: Gordon MacFarlane
• Owner & Operator: Actim Oy
• Contact Address: Klovinpellontie 3 ; Espoo FI-ES Etela-Suomen laani FI-02180 FI
• Official Correspondent:
  • Elina Carlson
  • 358-9-547680-x
• US Agent:
  • Gordon MacFarlane
  • ICONplc
  • 919 8738962
  • 215 6996288
  • Gordon.MacFarlane@iconplc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2100 Pennbrook Pkwy ; North Wales, PA 19454 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 1000212994
• FEI Number: 1000212994
• Name: Gordon MacFarlane
• Owner & Operator: Actim Oy
• Contact Address: Klovinpellontie 3 ; Espoo FI-ES Etela-Suomen laani FI-02180 FI
• Official Correspondent:
  • Elina Carlson
  • 358-9-547680-x
• US Agent:
  • Gordon MacFarlane
  • ICONplc
  • 919 8738962
  • 215 6996288
  • Gordon.MacFarlane@iconplc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2100 Pennbrook Pkwy ; North Wales, PA 19454 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06430030990622 Actim Oy	Actim PROM Controls	2019-12-05
GUDID 06430030990615 Actim Oy	Actim PROM	2019-12-05
PMN K123986 | OAM Gordon MacFarlane [Actim Oy]	Actim PROM	2014-11-28
PMN K123986 | OAM Gordon MacFarlane [Actim Oy]	Actim PROM	2014-11-28
PMN K123986 | OAM Gordon MacFarlane [Actim Oy]	Actim PROM Controls	2014-11-28
PMN K123986 | OAM Gordon MacFarlane [Actim Oy]	Actim PROM Controls	2014-11-28