BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BELLUS MEDICAL, LLC

    Reg #: 3010392991 · FEI: 3010392991 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    BELLUS MEDICAL, LLC
    Registration Number
    3010392991
    FEI Number
    3010392991
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    207 Mockingbird Ln
    City
    Johnson City
    State
    TN
    ZIP
    37604
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200017

    Owner / Operator

    Firm Name
    Bellus Medical, LLC
    Operator Number
    10044925
    Address
    207 Mockingbird Lane
    City
    Johnson City
    State
    TN
    Postal Code
    37604
    Country
    US

    Products

    Device Name Product Code
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Needle, Hypodermic, Single Lumen FMI
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Powered Microneedle Device QAI
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Needle, Aspiration And Injection, Disposable GAA
    Disinfector, Medical Devices MEC

    Proprietary Names

    DermaFlex MicroCannula Healeon HD PRP Gold Rush PRP BTR PRP ProGen PRP Eclipse Genesis PRP SkinPen Precision Elite Boost 2+ Flex 18G X 1" Venting Needle; 30G X 1/2" Hypodermic Needle DermaFlex Aspiration Needle SkinPen Precision System PRP Float EVO Decontaminator MicroPen EVO

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility