BEUDAMED
    EU Manufacturer ๐Ÿ‡ฎ๐Ÿ‡ณ India Active

    Chetan Meditech Pvt. Ltd.

    SRN: IN-MF-000013541 ยท Sanand II GIDC MD-04, 382110 Ahmedabad, Gujarat, India
    View on EUDAMED
    Basic UDI-DIs
    11
    Total Devices
    11
    On Market
    11
    Off Market
    0
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    3

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    Basic Information

    Address
    Sanand II GIDC MD-04, 382110 Ahmedabad, Gujarat, India
    Email
    [email protected]
    Phone
    +91 9316723174
    Website
    https://www.biotekortho.com/

    Regulatory Overview

    Regulation
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    Eu Mdr 7
    Eu Mdd 4
    Classification
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    Eu Md Class 2b 6
    Eu Md Class 1 2
    Eu Md Class 3 2
    Eu Md Class 2a 1
    Device Types
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    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 2021-MDD/QS-021 May 26, 2024
    MDD Annex II (excluding section 4) 2019-MDD/QS-067/A May 26, 2024
    MDR Technical Documentation 2024-MDR/TD-031 โ€”

    Market Presence

    Devices from this manufacturer are available in 3 countries across Europe.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ซ๐Ÿ‡ท France

    Device Portfolio

    Name
    ARTHROVIMS ANCHOR LRP
    ArthroVIMS ANCHOR LRP
    ArthroVims BR
    BIO-VIM
    BIOTEK
    BIOTEK, Fiberknot, ArthroVims Soft Anchor, ArthroVims
    BioFiber
    BioFix-NP
    ONLoc
    SOFTFIX-PK
    SURESHOT