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Plusoptix GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000006138 FEI 3003829667

Devices
8
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Plusoptix GmbH makes

Plusoptix GmbH manufactures handheld retinal cameras and vision screeners designed for non-mydriatic imaging of the retina. These devices include models like the plusoptiX S16, S12C, and S20 Vision Screener, which capture detailed retinal images for diagnostic purposes. Additional models, such as the plusoptiX A12R and A20, are configured for automated analysis of retinal features. The portfolio also includes portable devices like the plusoptiX A16 and A12C, intended for use in clinical and screening settings.

The company’s devices are classified under Class I in the EU regulatory framework and are listed in the eudamed database. These products are intended for use within the European Union’s medical device regulations. The manufacturer is based in Germany.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • plusoptiX S16

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • plusoptiX A12R

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • plusoptiX S12C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • plusoptiX A20

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • plusoptiX S12R

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • plusoptiX A16

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • plusoptiX S20 Vision Screener

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • plusoptiX A12C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Company details

EUDAMED SRN
DE-MF-000006138
FDA FEI number
3003829667
DUNS number
332755078
EU VAT number
DE232255629
EUDAMED status
Active
EUDAMED registered name
Plusoptix GmbH
Registered address
21, Nordostpark, 90411, Nürnberg, Germany
PRRC contact
Roland Kranz(public in EUDAMED)

Frequently asked questions

How many devices does Plusoptix GmbH have in the registry?

The registry currently lists 8 devices for Plusoptix GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Plusoptix GmbH's devices?

Among its 8 most recently registered devices, Plusoptix GmbH has devices listed in EUDAMED (8 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Plusoptix GmbH's devices fall under?

Among its 8 most recently registered devices, the classes recorded for Plusoptix GmbH's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Plusoptix GmbH in the registry?

The most recently registered devices listed for Plusoptix GmbH include plusoptiX S16, plusoptiX A12R, plusoptiX S12C and plusoptiX A20.

Generated automatically from registry data and not verified by a human reviewer.