BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UNICARE BIOMEDICAL, INC.

    Reg #: 2032542 · FEI: 3003646540 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    UNICARE BIOMEDICAL, INC.
    Registration Number
    2032542
    FEI Number
    3003646540
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23011 Moulton Pkwy Ste J11
    City
    Laguna Hills
    State
    CA
    ZIP
    92653
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092567

    Owner / Operator

    Firm Name
    UNICARE BIOMEDICAL, INC.
    Operator Number
    9034652
    Address
    23011 Moulton Pkwy, Ste J11
    City
    Laguna Hills
    State
    CA
    Postal Code
    92653
    Country
    US
    Correspondent
    STAN - YANG

    Products

    Device Name Product Code
    Bone Grafting Material, Synthetic LYC
    Oral Wound Dressing OLR
    Wound Dressing With Animal-Derived Material(S) KGN
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Barrier, Synthetic, Intraoral NPK
    Barrier, Animal Source, Intraoral NPL
    Plate, Bone JEY

    Proprietary Names

    Unigraft Benacel Dental Dressing Curagen Benacel Plus Cytoflex Ti-Enforced Membrane Perforated Cytoflex Ti-Enforced Membrane Cytoflex Resorb Cytoflex Tefguard CollaFlex CYTOFLEX MESH

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility