Optomed Oy

FDA Filings

This page includes the latest FDA filings for Optomed 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: 3007710608
• FEI Number: 3007710608
• Name: Optomed Oy
• Owner & Operator: Optomed Oy
• Contact Address: Yrttipellontie 1 ; Oulu FI-OL Oulun laani 90230 FI
• Official Correspondent:
  • Jyri Leskela
  • 358-40-8309507-x
• US Agent:
  • Michael Van de Woude
  • Emergo by UL
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Yrttipellontie 1 ; Oulu Oulun laani, 90230 FI
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 06430046260672 Optomed Oy	Pictor M5WEY4 Volk FN	2021-11-23
GUDID 06430046260658 Optomed Oy	Pictor M5WEY4ES2 Volk FN	2021-11-23
GUDID 06430046260887 Optomed Oy	Volk Pictor Prestige retinal set	2019-12-12
GUDID 06430046260870 Optomed Oy	Volk Pictor Prestige full set	2019-12-12
GUDID 06430046260795 Optomed Oy	Optomed Aurora retinal set	2019-12-12
GUDID 06430046260757 Optomed Oy	Optomed Aurora full set	2019-12-12
GUDID 06430046260856 Optomed Oy	Signal set	2019-10-09
GUDID 06430046260832 Optomed Oy	Signal Camera	2019-10-08
PMN K180378 | HKI Optomed Oy	Signal Camera	2018-04-19
PMN K180378 | HKI Optomed Oy	Pictor Prestige Camera with Pictor Prestige Retina Module and Pictor Prestige Anterior Module	2018-04-19
PMN K180378 | HKI Optomed Oy	Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module	2018-04-19
PMN K180378 Optomed Oy	Optomed Aurora Camera With Aurora Retinal Module And Aurora Anterior Module	2018-04-05
PMN K163021 | HKI Optomed Oy	HAAG-STREIT FUNDUS MODULE 300	2017-05-16
PMN K163021 OPTOMED OY	HAAG-STREIT FUNDUS MODULE 300	2017-04-11
HKI Optomed Oy	Smartscope FA	2014-10-03
PMN K132186 | HKI Optomed Oy	VISUSCOUT 100	2014-09-26
PMN K132186 | HKI Optomed Oy	Pictor	2014-09-26
PMN K132186 | HKI Optomed Oy	Pictor Plus	2014-09-26
PMN K132186 | HKI Optomed Oy	Bosch Eye cam anterior module	2014-09-26
PMN K132186 | HKI Optomed Oy	Bosch Eye Camera	2014-09-26
PMN K132186 | HKI Optomed Oy	Bosch Eye Camera SWAN	2014-09-26
PMN K132186 OPTOMED OY	OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2	2013-12-18
PMN K110986 | HKI Optomed Oy	Smartscope M5 EY3	2011-08-02
PMN K110986 | HKI Optomed Oy	Smartscope M5 ES1	2011-08-02
PMN K110986 | HKI Optomed Oy	Bosch Eye cam posterior module	2011-08-02
PMN K110986 OPTOMED OY	OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1	2011-05-16
PMN K092056 OPTOMED OY	OPTOMED SMARTSCOPE, MODEL M3-1 EY1	2009-10-01