BEUDAMED
    Eu Mdd Eu Md Class 2b On The Market ๐Ÿ‡ซ๐Ÿ‡ฎ Finland

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    ProWellness Health Solutions Oy ยท ๐Ÿ‡ซ๐Ÿ‡ฎ Finland
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    32
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-FI-MF-000009237-12Q
    Basic UDI-DI Code
    B-FI-MF-000009237-12Q
    Reference
    D-FI-MF-000009237-12Q
    Device Types
    None provided
    Regulation
    Eu Mdd
    Classification
    Eu Md Class 2b
    Status
    On The Market
    Manufacturer
    ProWellness Health Solutions Oy

    Additional Description

    The device is a software indicated as an aid in insulin-requiring diabetes. The device is intended for use in providing insulin dose recommendations in response to blood glucose, insulin history, adjustments related to health events, and carbohydrate input within the scope of a pre-planned treatment program from a healthcare professional.

    CND Nomenclature Codes

    Code Description
    Z129082 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES

    Certificates

    Type Number
    MDD Annex II (excluding section 4) FI21/871841

    Available In Countries

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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