Optomed Oyj
Finland FI-MF-000009407 Last updated 21 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 18
- Registries
- EUDAMEDFDA 510(k)GUDID
- FDA recalls
- 0
Catalogue
Optomed Smartscope M5 with Optomed Smartscope FA Ref K201325
Visuscout 100 Ref 31000063
Topcon Signal Ref 41001596
Resusable eyecup Ref 30500005
Optomed Lumo Charging Station Ref 41002612
Visuscout 100 Ref 31000065
Optomed Aurora Ref 60101078A
Optomed Lumo Camera Ref 41002003
Optomed E-safe Ref 30001937
Optomed Aurora Ref 41000652
Optomed Aurora Ref 41000651
Smartscope Ref 41000023
Optomed Smartscope Ref 41000040
Signal Camera Ref 41001595
Optomed Aurora Ref 41000653
Optomed Aurora camera Ref 41000650
Optomed Lumo Desktop Base Ref 41002004
Optomed Aurora Ref 60100635A
EUDAMED certificates
SGS FIMKO OY 0598 2 certificates
- FI24/00000061 Reissued
Quality management system EU MDR
- Issued
- 17 Jun 2025
- Expires
- 16 Jun 2030
- FI24/00000061 Supplemented
Quality management system EU MDR
- Issued
- 14 Mar 2025
- Expires
- 5 Jun 2029
- Reason
- Change approved
Related companies
Notified bodies
- SGS FIMKO OY 0598
About
Discover Optomed’s handheld fundus camera with optional AI for retinal imaging and screening. Non-mydriatic and clinically validated.
What Optomed Oyj makes
Optomed manufactures handheld fundus cameras, including models like the Smartscope M5 and Visuscout 100, designed for retinal imaging and non-mydriatic screening. Their portfolio also includes reusable eyecups, portable imaging devices such as the Topcon Signal and Signal Camera, and accessories like the Lumo Charging Station and Lumo Camera. Additional offerings include the Optomed Aurora, a fundus camera system, and the E-safe, a safety-focused device for retinal imaging.
The company’s devices are classified under EU regulations as Class I, Class II, and Class IIa, with listings in the EUDAMED database and FDA’s 510(k) registry. Optomed is headquartered in Finland and adheres to regulatory requirements for medical imaging equipment in both European and U.S. markets.
Information
- Country
- Finland
- Address
- 1, Yrttipellontie, Oulu, Finland
- Website
- www.optomed.com
- linkedin.com/company/optomedplc
- facebook.com/OptomedPlc
- [email protected]
- Phone
- +358 40 8309507
- PRRC contact
- Jyri Leskelä
- EUDAMED SRN
- FI-MF-000009407