BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CHEMENCE MEDICAL INC.

    Reg #: 3010034760 · FEI: 3010034760 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    18
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    CHEMENCE MEDICAL INC.
    Registration Number
    3010034760
    FEI Number
    3010034760
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 Technology Dr
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050757

    Owner / Operator

    Firm Name
    CHEMENCE MEDICAL INC.
    Operator Number
    9054055
    Address
    200 Technology Drive
    City
    Alpharetta
    State
    GA
    Postal Code
    30005
    Country
    US

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    Bandage, Liquid, Skin Protectant NEC
    Bandage, Liquid KMF
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Solvent, Adhesive Tape KOX
    Cutaneous Tissue Adhesive With Mesh OMD
    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations KGG

    Proprietary Names

    Exofin Mastic Liquid Skin derma+flex gel adhesive Leukosan Ultra-High Viscosity Cyanoacrylate exofin Precision Pen Premier Pro Exofin Precision Pen GluGone derma+flex QS Tissue Adhesive derma+flex derma+flex® QS™ exofin® SC exofin High Viscosity Topical Skin Adhesive exofin High Viscosity Adhesive Exofin Fusion Skin Closure System exofin High Viscosity Tissue Adhesive Exofin Micro Premier Pro exofin High Viscosity Tissue exofin Fusion

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198