BEUDAMED
    EU Manufacturer ๐Ÿ‡ฎ๐Ÿ‡น Italy Active

    BETATEX SPA

    SRN: IT-MF-000009955 ยท VIA RAFFAELLO 2, 06081 ASSISI, Italy
    View on EUDAMED
    Basic UDI-DIs
    9
    Total Devices
    9
    On Market
    7
    Off Market
    2
    Certificates
    5
    Valid
    1
    Expiring < 6mo
    0
    Countries
    11

    Basic Information

    Address
    VIA RAFFAELLO 2, 06081 ASSISI, Italy
    Email
    [email protected]
    Phone
    +390758004872
    Website
    www.betatex.com

    Regulatory Overview

    Regulation
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    Eu Mdd 6
    Eu Mdr 3
    Classification
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    Eu Md Class 1 3
    Eu Md Class 2a 3
    Eu Md Class 2b 3

    Certificate Health

    Total
    5
    Valid
    1
    Expiring < 6mo
    0
    Expired / Withdrawn
    4
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) QCT-0036-17 May 07, 2022
    MDD Annex V G2 003920 0003 Sep 26, 2023
    MDD Annex V G2S 003920 0004 Sep 26, 2023
    MDD Annex V G2S 003920 0004 Sep 26, 2023
    MDR QMS CSQ0001220223 Oct 23, 2027 Supplemented

    Market Presence

    Devices from this manufacturer are available in 11 countries across Europe.

    ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

    Device Portfolio

    Name
    CUSTOM PACK CATARATTA
    KIT PER CATETERISMO VESCICALE
    M-connect - CONNECTING TUBE MLL 3WAYS STOPCOCK/FUNNEL 15CM
    MTT1010/BX-15_AV2 A SET PROCEDURALE CHIR
    PICC LINE DRESSING KIT
    PICC Line Dressing Kit
    SET BY PASS AORTOCORONARICO
    SIRINGA GEL LUBRIFICANTE
    TELO 75X120 CM IN SUPER ASSORBENTE