BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    NIDACON INTERNATIONAL AB

    Reg #: 9616005 · FEI: 3004848623 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    NIDACON INTERNATIONAL AB
    Registration Number
    9616005
    FEI Number
    3004848623
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FLOJELBERGSGATAN 16B
    City
    MOLNDAL Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K011606

    Owner / Operator

    Firm Name
    NIDACON INTERNATIONAL AB
    Operator Number
    9033529
    Address
    FLOJELBERGSGATAN 16B, --
    City
    MOLNDAL
    State
    Vastra Gotaland
    Postal Code
    SE-431 37
    Country
    SE

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    847 3741727

    Products

    Device Name Product Code
    Media, Reproductive MQL
    Labware, Assisted Reproduction MQK
    Eosin Y HYB

    Proprietary Names

    PURESPERM BUFFER-PSB-100 Thermoblast-TBK-010 Vitriblast-VBK-010 ProInsert-PI15-5 NidOil-NO-400 NidOil-NO-100 PureSperm® 100 PureSperm® 100K PureSperm 100-PS100-250 PureSperm 100-PS100-1000K PureSperm 100-PS100-100 SpermCryoProtec-SCP-020 CryoFloater Vial-CFV-001 CryoFloater Straw-CFS-001 PureSperm SpeedKit PureSperm 80-PS80-100 PureSperm 40/80-PSK-020 PureSperm 90-PS90-100 PureSperm SpeedKit-PSSK-010 PureSperm 40-PS40-100 PureSperm 80-PSUL SPERMCATCH PURESPERM WASH-PSW PURESPERM WASH-PSW-100 PURESPERM WASH-PSW-020 SpermVitalStain-SVS-010

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility