BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amerx Healthcare Corp

    Reg #: 3012535730 · FEI: 3012535730 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    9

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    Registration Details

    Registration Name
    Amerx Healthcare Corp
    Registration Number
    3012535730
    FEI Number
    3012535730
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    164 Douglas Road East
    City
    Oldsmar
    State
    FL
    ZIP
    34677
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122325

    Owner / Operator

    Firm Name
    Amerx Health Care Corporation
    Operator Number
    10029882
    Address
    164 Douglas Road East
    City
    Oldsmar
    State
    FL
    Postal Code
    34677
    Country
    US
    Correspondent
    Lisa Capote

    Products

    Device Name Product Code
    Wound Dressing With Animal-Derived Material(S) KGN
    Dressing, Wound, Occlusive NAD
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Dressing, Wound, Hydrophilic NAC
    Lavage, Jet FQH
    Dressing, Wound, Drug FRO
    Stocking, Medical Support (For General Medical Purposes) FQL
    Gauze / Sponge,Nonresorbable For External Use NAB
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    Hydrocolloid pad thin 4 x 4 Hydrocolloid pad thin 2 x 2 Hydrocolloid pad 2 x 2 Hydrocolloid pad 4 x 4 Amerigel Ointment Calcium Alginate Pad 4 x 4 Foam 4 x 4 Foam with adhesive 4 x 4 Foam 2 x 2 Foam with adhesive 2 x 2 Wound Wash Amerigel Ointment Saturated Wound D Extremit-Ease (various sizes) 2x2 non-sterile non-woven 4 ply gauze Bordered Gauze Dressing 1 x 1 Bordered Gauze Dressing 4.25 x 4.25 Bordered Gauze Dressing 2 x 2 Bordered Gauze Dressing 4 x 10 1x3 fabric bandage 1.5x3 H Shaped Bandage 1x5 cohesive wrap (flex tape) Amerx Wound Wash

    Establishment Types

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