BEUDAMED
    Notified Body NB 0318 🇪🇸 Spain

    CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

    Campezo 1. Edificio 7., 28022 MADRID, Spain
    View on EUDAMED
    Updated Mar 16, 2023
    Certificates
    32
    Valid
    0
    Expiring < 6mo
    0
    Expired
    30
    Basic UDI-DIs
    340
    Devices
    340
    Manufacturers
    18
    Cert. Types
    6

    Basic Information

    Address
    Campezo 1. Edificio 7., 28022 MADRID, Spain
    Email
    [email protected]
    Phone
    +34:91:822 51 30
    Website
    www.certificaps.gob.es

    Regulatory Overview

    Regulation
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    Eu Mdd 328
    Eu Ivdd 12
    Classification
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    Eu Md Class 2a 151
    Eu Md Class 2b 148
    Eu Md Class 3 29
    Eu Ivd Annex 2 List A 6
    Eu Ivd Annex 2 List B 3
    Eu Ivd Self Testing 3
    Device Types
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    Certificate Health

    Total
    32
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    30
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 2020 07 0931 CT May 14, 2021
    MDD Annex II (excluding section 4) 2021 05 0959 CT May 24, 2021
    IVDD Annex IV Section 6 2019 03 0883 CT May 26, 2023
    MDD Annex II (excluding section 4) 2013 07 0802CT Jul 14, 2023
    MDD Annex II (excluding section 4) 2013 07 0802 CT Jul 14, 2023
    MDD Annex V 98050101CP Jan 27, 2024
    IVDD Annex IV (excluding sections 4, 6) 2015 07 0840 CT May 25, 2024
    MDD Annex VI 2012070789CD May 25, 2024
    MDD Annex II (excluding section 4) 2007 12 0534 CT May 26, 2024
    MDD Annex II (excluding section 4) 2021020951CT May 26, 2024
    MDD Annex II Section 4 2021020952ED May 26, 2024
    MDD Annex II Section 4 2021020953ED May 26, 2024
    MDD Annex II (excluding section 4) 2017080864CT May 26, 2024
    MDD Annex II (excluding section 4) 2013 10 0804 CT May 26, 2024
    MDD Annex II Section 4 2013 10 0805 ED May 26, 2024
    MDD Annex II (excluding section 4) 2020 06 0930 CT May 26, 2024
    MDD Annex II (excluding section 4) 2021 05 0957 CT May 26, 2024
    MDD Annex II Section 4 2021 05 0958 ED May 26, 2024
    MDD Annex II (excluding section 4) 2004 12 0464 CT May 26, 2024
    MDD Annex II (excluding section 4) 2004 12 0464 CT May 26, 2024
    MDD Annex II (excluding section 4) 2016 05 0849 May 26, 2024
    MDD Annex II (excluding section 4) 2016 05 0849 CT May 26, 2024
    MDD Annex II (excluding section 4) 2020 12 0946 CT May 26, 2024
    MDD Annex II (excluding section 4) 2020 12 0945 CT May 26, 2024
    MDD Annex II (excluding section 4) 2001 01 0301 CT May 26, 2024
    IVDD Annex IV (excluding sections 4, 6) 2005 12 0495 CT May 26, 2024
    MDD Annex II (excluding section 4) 2018 06 0873 CT May 26, 2024
    MDD Annex II (excluding section 4) 2018 06 0872 CT May 26, 2024
    IVDD Annex IV (excluding sections 4, 6) 2022050976CT May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) 2022 04 0975 CT May 26, 2025
    MDD Annex II (excluding section 4) 2021 05 0960 CT Dec 31, 2027
    MDD Annex II (excluding section 4) 2021 05 0960 CT Dec 31, 2027

    Manufacturer Portfolio

    Manufacturer Certificates
    LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A. 5
    i+Med S.Coop. 4
    VEC MEDICAL SPAIN, S.L. 3
    Tuylek, s.l. 2
    S.E. Carburos Metálicos, S.A. 2
    VIMAP TECHNOLOGIES, S.L.U 2
    histocell 2
    PEGISDAN, S.R.L.U. 2
    SISTEMAS GENOMICOS. S.L. 1
    Oxigen Salud, S.A. 1
    MEDICOVER GENETICS LIMITED 1
    LABORATORIO REIG JOFRE, S.A. 1
    BIOLAN HEALTH, S.L. 1
    F&M CONTROL, S.L. 1
    MedMira Laboratories Inc. 1
    VITRO, S.A. 1
    S.A. PRODER 1
    Unolab manufacturing, S.L. 1