BEUDAMED
    EU Manufacturer ๐Ÿ‡ฉ๐Ÿ‡ช Germany Active

    Roche Diabetes Care GmbH

    SRN: DE-MF-000006276 ยท Sandhofer Strasse 116, 68305 Mannheim, Germany
    View on EUDAMED
    Basic UDI-DIs
    10
    Total Devices
    10
    On Market
    10
    Off Market
    0
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    15

    Basic Information

    Address
    Sandhofer Strasse 116, 68305 Mannheim, Germany
    Email
    [email protected]
    Website
    accu-chek.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 8
    Eu Mdd 2
    Classification
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    Eu Ivd Annex 2 List B 8
    Eu Md Class 2b 2
    Device Types
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    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) G1 092547 0014 Apr 30, 2024
    MDD Annex II (excluding section 4) G1 0925470014 Apr 30, 2024
    IVDD Annex IV (excluding sections 4, 6) V1 092547 0015 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 15 countries across Europe.

    ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia

    Device Portfolio

    Name
    Accu-Chek
    Accu-Chek Aviva
    Accu-Chek Guide
    Accu-Chek Insight
    Accu-Chek Instant
    Accu-Chek Instant
    Accu-Chek Mobile
    Accu-Chek Mobile
    Accu-Chek Solo
    Accu-Chek Spirit Combo