BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    CARESYN® - Polyglycolic Acid; CARESYN® RAPID, Synthetic Absorbable Suture

    Reg #: 3018064853 · FEI: 3018064853 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CPT SUTURES CO., LTD.
    Registration Number
    3018064853
    FEI Number
    3018064853
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Dao Tri Street, Phu Thuan Ward, District 7
    City
    Ho Chi Minh
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K170166

    Owner / Operator

    Firm Name
    CPT SUTURES CO., LTD.
    Operator Number
    10080643
    Address
    8 Dao Tri Street, Phu Thuan Ward, District 7
    City
    Ho Chi Minh
    State
    VN-SG
    Postal Code
    700000
    Country
    VN
    Correspondent
    Khoa Do

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd., Suite 200
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    CARESYN® - Polyglycolic Acid; CARESYN® RAPID, Synthetic Absorbable Suture TEKSYN® 910 - Polyglactin 910 (PGLA); Rapid (fast absorbing) TEKSYN® PGA - Polyglycolic Acid (PGA); Rapid, Synthetic Absorbable Suture CARESORB® - Polyglactin 910; CARESORB® RAPID (fast absorbing)

    Establishment Types

    Manufacture Medical Device