BEUDAMED
    FDA Registration Active 🇮🇳 India

    ADROIT MANUFACTURING CO.

    Reg #: 3009401905 · FEI: 3009401905 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ADROIT MANUFACTURING CO.
    Registration Number
    3009401905
    FEI Number
    3009401905
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot No: 138 (EXPN, AREA), GIDC, Dist. Valsad
    City
    Umbergaon Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K000117

    Owner / Operator

    Firm Name
    ADROIT MANUFACTURING CO.
    Operator Number
    10040349
    Address
    Plot No: 138, Dist. Valsad
    City
    Umbergaon
    State
    Gujarat
    Postal Code
    396171
    Country
    IN

    US Agent

    Business Name
    SPECTRA MEDICAL DEVICES, LLC
    Contact Name
    Kathy Dassler
    Address
    299 BALLARDVALE STREET, SUITE 1
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US
    Email
    [email protected]
    Phone
    978 6570889 ext. 5224

    Products

    Device Name Product Code
    Set, Anesthesia, Paracervical HEE
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    SET, ANESTHESIA,PARACERVICAL Tunneler Trocar

    Establishment Types

    Manufacture Medical Device