BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti

    Reg #: 3008045828 · FEI: 3008045828 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti
    Registration Number
    3008045828
    FEI Number
    3008045828
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zafer SB MAh Gunduz Sk No:13 Ege Serbest Bolge Gaziemir IZmir
    City
    Izmir
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K092783

    Owner / Operator

    Firm Name
    Lansinoh Laboratories Saglik Ger. Tas. San. Tic. Ltd. Sti.
    Operator Number
    10030867
    Address
    Zafer SB Mah. Gunduz Sk. No:13, Gaziemir
    City
    Izmir
    State
    TR-35
    Postal Code
    35035
    Country
    TR
    Correspondent
    Barbaros Karadag

    US Agent

    Business Name
    Lansinoh Laboratories Ins.
    Contact Name
    Jeff VanderHoek
    Address
    99 Canal Center Plz
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    760 2015607

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Pump, Breast, Non-Powered HGY

    Proprietary Names

    Affinity Double Electr Breast Pump Smartpump 3 Double Electric Breast Pump NaturalWave Double Electric Breast Pump Compact Wearable Pump Signature Comfort Double Electric Breast Pump Signature Pro Double Electric Breast Pump Smartpump 2 Double Electric Breast Pump Soothies C-section Recovery Pads Lansinoh Manual Breast Pump Primo-Lacto Hand Expression Funnel Slipfit Primo-Lacto Hand Expression Funnel Enfit Primo-Lacto Ameda Slipfit Primo-Lacto Ameda Enfit Primo-Lacto Medela/Lansinoh Enfit Primo-Lacto Medela/Lansinoh Slipfit Contact Nipple Shields 24mm Contact Nipple Shields 20mm SILICONE BREAST PUMP Contact Nipple Shields 16mm

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility