BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DEMETECH CORP.

    Reg #: 1064584 · FEI: 3003063934 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    19

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    Registration Details

    Registration Name
    DEMETECH CORP.
    Registration Number
    1064584
    FEI Number
    3003063934
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5980 Miami Lakes Drive
    City
    Miami Lakes
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181578

    Owner / Operator

    Firm Name
    DEMETECH CORP.
    Operator Number
    9041973
    Address
    5980 Miami Lakes Drive, --
    City
    Miami Lakes
    State
    FL
    Postal Code
    33014
    Country
    US

    Products

    Device Name Product Code
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Tube, Collection, Capillary Blood GIO
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Absorbable, Natural GAL
    Retention Device, Suture KGS
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Silk GAP
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    System, Blood Collection, Vacuum-Assisted, Manual KST
    Mixer, Blood Tube GLE
    Mesh, Surgical, Polymeric FTL
    Respirator, Surgical MSH
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Insufflator, Laparoscopic HIF
    Mask, Surgical FXX

    Proprietary Names

    DemeTECH PTFE-Polytetrafluoroethylene Nonabsorbable Suture Spigot Guard - Urine Collection Bag Drain Cap DemeCRYL DemeSORB DemeDIOX Barbed DemeDIOX DemeTECH Polydioxnone Synthetic Monofilament (PDO) Suture DemeGUT Chromic DemeGUT DemeGUT Plain Demetech Chromic Catgut Suture Demetech Plain Catgut Suture HemiGard Adhesive Suture Retention Device SutureGard Suture Retention Device DemeLON DemeSILK DemeSTEEL DemeCAPRONE DemeTUBE PRF DemeLENE Mesh DemeMASK N95 Respirator DemeMASK DemeQUICK DemeBOND DemeDIOX with Novathreads-Absorbable Polydioxane Surgical Suture DemeDIOX Barbed with Novathreads-Absorbable Polydioxane Surgical Suture DemeLENE DemeMASK Surgical Mask DemeFORCE UHMWPE

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)