BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Kimono

    Reg #: 3005191252 · FEI: 3005191252 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY
    Registration Number
    3005191252
    FEI Number
    3005191252
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, JALAN KILANG TIGA, JELAPANG LIGHT IND. ESTATE
    City
    IPOH Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K946374

    Owner / Operator

    Firm Name
    SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY
    Operator Number
    9073700
    Address
    2, JALAN KILANG TIGA, JELAPANG LIGHT IND. ESTATE
    City
    IPOH
    State
    Perak
    Postal Code
    30100
    Country
    MY
    Correspondent
    MEI LEE - CHING

    US Agent

    Business Name
    Medqra, LLC
    Contact Name
    Richard Hettenbach
    Address
    589 Riverwood Dr. SE
    City
    Bolivia
    State
    NC
    ZIP
    28422
    Country
    US
    Email
    [email protected]
    Phone
    973 2147468

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    Kimono

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device