BEUDAMED
    FDA Registration Active 🇮🇳 India

    POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) -ORCA Foam

    Reg #: 3009403363 · FEI: 3009403363 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AEGIS LIFESCIENCES PRIVATE LIMITED
    Registration Number
    3009403363
    FEI Number
    3009403363
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    215/216, Mahagujarat Industrial Estate
    City
    Ahmedabad Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K060878

    Owner / Operator

    Firm Name
    Aegis Lifesciences Private Limited
    Operator Number
    10087601
    Address
    215/216, Mahagujarat Industrial Estate
    City
    Ahmedabad
    State
    Gujarat
    Postal Code
    382213
    Country
    IN
    Correspondent
    Mohit Gupta

    US Agent

    Business Name
    Pharma Regulatory Consultants LLC
    Contact Name
    Madan Chilakuri
    Address
    2829 Glenarye Dr
    City
    Lindenhurst
    State
    IL
    ZIP
    60046
    Country
    US
    Email
    [email protected]
    Phone
    207 7564065

    Products

    Device Name Product Code
    Splint, Intranasal Septal LYA
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ

    Proprietary Names

    POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) -ORCA Foam SPLINT, INTRANASAL SEPTAL - ORCA Foam

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)