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Optomed Oyj

Finland FI-MF-000009407 Last updated 21 Oct 2026

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Devices
18
Registries
EUDAMEDFDA 510(k)GUDID
FDA recalls
0

Catalogue18

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

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

Notified bodies

About

Discover Optomed’s handheld fundus camera with optional AI for retinal imaging and screening. Non-mydriatic and clinically validated.

From the manufacturer's own website. Source

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Finland
Address
1, Yrttipellontie, Oulu, Finland
Phone
+358 40 8309507
PRRC contact
Jyri Leskelä
EUDAMED SRN
FI-MF-000009407