BEUDAMED
    Authorized Representative 🇳🇱 Netherlands Active

    Delta Electronics (Netherlands) B.V.

    SRN: NL-AR-000001692 · Zandsteen 15, 2132 MZ Hoofddorp, Netherlands
    View on EUDAMED
    Manufacturers
    2
    Devices
    17
    Certificates
    4
    PRRCs
    1

    Basic Information

    Address
    Zandsteen 15, 2132 MZ Hoofddorp, Netherlands
    Email
    [email protected]

    Non-EU Manufacturers

    Name
    Delta Electronics, Inc.
    DELBIO INC.

    Manufacturers

    DELBIO INC.

    Manufacturer
    🇹🇼 Taiwan·7 Basic UDI-DIs·14 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Delta Electronics, Inc.

    Manufacturer
    🇹🇼 Taiwan·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH

    Certificates

    Type Number
    MDD Annex II (excluding section 4) HD 2339568-1
    MDD Annex II (excluding section 4) HD2339568-1
    MDD Annex II (excluding section 4) HD 2339568-1
    MDD Annex II (excluding section 4) HD 60150337 0001

    Devices

    PULSE OXIMETERS

    Device
    EU MDD · Eu Md Class 2a ·DELBIO INC.·No longer on the market·1 country

    SPENGLER

    Device
    EU MDD · Eu Md Class 2a ·DELBIO INC.·On the market·1 country

    SPENGLER

    Device
    EU MDD · Eu Md Class 2a ·DELBIO INC.·On the market·1 country

    SPENGLER

    Device
    EU MDD · Eu Md Class 2a ·DELBIO INC.·On the market·1 country

    Aposán

    Device
    EU MDD · Eu Md Class 2a ·DELBIO INC.·On the market·1 country

    DELBIO GS2 Nucleic Acid Extraction Kit

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market

    GS Nucleic Acid Extraction Kit

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market

    Vircell GS Nucleic Acid Extraction Kit

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·2 countries

    DELBIO GS1 Nucleic Acid Extraction Kit

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·32 countries

    DELBIO GS2 Nucleic Acid Extraction Kit

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·32 countries

    MiniLab System

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market

    Vircell Molecular Analysis POC System G1

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·2 countries

    DELBIO Automated Nucleic Acid Analysis System

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·32 countries

    DELBIO Automated Nucleic Acid Analysis System

    Device
    EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·32 countries

    DELTA

    Device
    EU MDD · Eu Md Class 2b ·Delta Electronics, Inc.·On the market·1 country

    DELTA

    Device
    EU MDD · Eu Md Class 2b ·Delta Electronics, Inc.·On the market·1 country

    DELTA

    Device
    EU MDD · Eu Md Class 2b ·Delta Electronics, Inc.·On the market·1 country