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Ewoosoft Co., Ltd.

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Ewoosoft Co., Ltd. is a medical device manufacturer, with 62 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.

Devices
62

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 31
  • FDA GUDID 29
  • EUDAMED 6

A device listed in two registries counts in both.

Device classes
  • FDA Class II 60
  • EU Class IIa 2
Top EMDN categories
Sites and related companies

What Ewoosoft Co., Ltd. makes

Ewoosoft Co., Ltd. develops software applications for general-purpose dental X-ray systems, including tools for imaging analysis, orthodontic planning, and diagnostic viewing. Their portfolio includes solutions like Ez3D-i, EzDent-i, EzOrtho, OrthoVision, Ez3D Plus, and Smart M Viewer, designed to enhance intraoral and 3D dental imaging workflows.

The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s 510(k) and UDI registries.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue62

Newest first, rows 1-50 of 62

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  • EzOrtho

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Prora View

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ez3D-i 5.5

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

  • EzDent-i v2.1

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

  • EzDent-i v3.0

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

  • EzOrtho 1.2

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

  • EzDent-i v3.2

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

  • OrthoVision v2.1

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

  • EzDent-i v2.2

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

  • EzOrtho 1.1

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

  • Ez3D-i v5.0

    Listed Registry: GUDID Class:II

  • Ez3D-i v4.1

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

  • Ez3D Plus v1.2

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

  • Smart M Viewer v3.0

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

  • Clever One 1.0

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

  • Ez3D-i 5.4

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

  • Ez3D-i v5.2

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

  • EzDent-i 3.3

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

  • OrthoVision v2.0

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

  • EzMobile v1.1

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

  • EzDent-i v2.3

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

  • Ez3D-i v5.3

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

  • Ez3D-i v5.1

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

  • EzDent-i 3.4

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

  • EzOrtho 1.3

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

  • EzDent Web v1.2

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

  • EzDent Web v1.0

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

  • EzDent-i 3.5

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

  • EzDent-i v3.1

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

  • EzOrtho 1.0

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

  • Ez3D-i v4.3

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

  • Ez3D-i/E3 Ref K211791

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

  • OrthoVision Ref K173094

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

  • Ez3D Plus Ref K152746

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

  • EzDent Web Ref K230468

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

  • EzDent Web Ref K211700

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

  • EzDent-i / E2 / Prora View Ref K161117

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

  • Ez3D-i/E3 Ref K150761

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

  • Clever One Ref K250005

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

  • EzMobile Ref K192098

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

  • Ez3D-i / E3 Ref K161246

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

  • EzDent-i / E2 / Prora View/ Smart M Viewer Ref K222145

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

  • Ez3D-i /E3 Ref K173863

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

  • Ezdenti-I; E2; Prora View Ref K131594

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

  • EzDent-i / E2 / Prora View/ Smart M Viewer Ref K223820

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

  • Ez3D-i /E3 Ref K200178

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

  • EzDent-i/ E2/ Prora View/ Smart M Viewer Ref K211795

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

  • EzOrtho Ref K202948

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

  • Ez3D-i / E3 Ref K163539

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

  • EzOrtho Ref K192888

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

Rows 1-50 of 62

Showing 1-50 of 62

Sites1

Frequently asked questions

How many devices does Ewoosoft Co., Ltd. have in the registry?

The registry currently lists 62 devices for Ewoosoft Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ewoosoft Co., Ltd.'s devices?

Among its 50 most recently registered devices, Ewoosoft Co., Ltd. has devices listed in EUDAMED (6 devices), FDA 510(k) (19 devices) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ewoosoft Co., Ltd.'s devices fall under?

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

What are the newest devices from Ewoosoft Co., Ltd. in the registry?

The most recently registered devices listed for Ewoosoft Co., Ltd. include EzOrtho, Prora View, Ez3D-i 5.5 and EzDent-i v2.1.

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