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Ecleris

Country not established FDA

Devices
153
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Ecleris makes

Ecleris manufactures optical and video-based medical imaging devices for surgical and diagnostic procedures, including general-purpose surgical microscopes, colposcopes, and rigid optical sinoscopes. Their portfolio also includes otoscopes, endoscopic otoscopes, rigid optical rhinolaryngoscopes, flexible video laryngoscopes, and surgical video cameras, often paired with general-purpose light sources for enhanced visualization. Specific products include systems like the Procam HD II and LaryngoPro, designed for procedures in otolaryngology, sinus surgery, and gynecology.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to regulatory requirements for medical imaging equipment.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue153

Newest first, rows 1-50 of 153

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  • Portaled R00

    Listed Registry: GUDID Class:I

  • Portaled RX1

    Listed Registry: GUDID Class:I

  • Procam 4K R00

    Listed Registry: GUDID Class:I

  • Procam 4K Usb RX1

    Listed Registry: GUDID Class:I

  • Procam HD CMOS II R04

    Listed Registry: GUDID Class:I

  • Procam 4K R00

    Listed Registry: GUDID Class:I

  • Microscope R02

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Procam Pack RX1

    Listed Registry: GUDID Class:I

  • LaryngoPro R00

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Everlux R02

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Laringoscope R00

    Listed Registry: GUDID Class:I

  • Procam HD II RX1

    Listed Registry: GUDID Class:I

  • Procam Hd 2D R00

    Listed Registry: GUDID Class:I

  • Minivac R02

    Listed Registry: GUDID Class:I

  • Everlux Mini R00

    Listed Registry: GUDID Class:I

  • Laringoscope R00

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • MICROSTAR Colposcope R01

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Microscope R00

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Procam Sd R00

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • MICROSCOPE Colposcope RX1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Fns-2800 RX1

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Microscope R00

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • MICROSCOPE Colposcope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Everlux Pro R00

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • MICROSCOPE Colposcope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Microscope R00

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Vng 3D R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • MICROSCOPE Colposcope RX1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Otoscope R00

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Microscope R01

    Listed Registry: GUDID Class:I

  • Microscope RX1

    Listed Registry: GUDID Class:I

  • Microscope R00

    Listed Registry: GUDID Class:I

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Sinuscope R00

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Everlux R02

    Listed Registry: GUDID Class:I

Rows 1-50 of 153

Showing 1-50 of 153

Company details

DUNS number
043555079
Phone
786-483-7490

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Ecleris SRL Villa Martelli Buenos Aires · AR FEI 3005216736

Frequently asked questions

How many devices does Ecleris have in the registry?

The registry currently lists 153 devices for Ecleris. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ecleris's devices?

Among its 50 most recently registered devices, Ecleris has devices listed in EUDAMED (1 device) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ecleris's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Ecleris's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ecleris in the registry?

The most recently registered devices listed for Ecleris include PORTALED R00, PORTALED RX1, Procam 4K R00 and PROCAM 4K USB RX1.

Which FDA establishments are linked to Ecleris?

1 FDA establishment is linked to Ecleris in the registry; they are listed on the company page.

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