BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    COLOPLAST HUNGARY KFT

    Reg #: 3006606901 · FEI: 3006606901 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    49
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    COLOPLAST HUNGARY KFT
    Registration Number
    3006606901
    FEI Number
    3006606901
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    COLOPLAST UTCA 2
    City
    NYIRBATOR Szabolcs-Szatmar-Bereg
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K200142

    Owner / Operator

    Firm Name
    Coloplast Corp.
    Operator Number
    8010144
    Address
    1601 West River Road North
    City
    Minneapolis
    State
    MN
    Postal Code
    55411
    Country
    US

    US Agent

    Business Name
    COLOPLAST CORP.
    Contact Name
    Jason Woehrle
    Address
    1601 West River Road N
    City
    Minneapolis
    State
    MN
    ZIP
    55411
    Country
    US
    Email
    [email protected]
    Phone
    612 7302063

    Products

    Device Name Product Code
    Catheter, Urethral GBM
    Dressing, Wound, Drug FRO
    Catheter, Straight EZD
    Device, Incontinence, Urosheath Type, Non-Sterile NNX
    Enema Kit FCE
    Tubes, Gastrointestinal (And Accessories) KNT
    Fiber, Medical, Absorbent FRL
    Rod, Colostomy EZP
    Dressing, Wound, Occlusive NAD

    Proprietary Names

    SpeediCath Soft Biatain Silicone AG Luja Set FREEDOM Penilex CONVEEN OPTIMA Self-Cath Extension Tube CONVEEN SECURITY + SpeediCath Compact Plus SpeediCath Compact Luja Coude Sure Cath Set Peristeen Plus SpeediCath Flex Set SpeediCath Flex Set with Accessories SpeediCath Compact Set Female Self-Cath Self-Cath Plus SpeediCath Compact Male SpeediCath Compact Male Kit BAND-AID Hydroseal Acne Blemish Patch Neutrogena Acne Blemish Patch Biatain Ag Adhesive Biatain Ag Non-Adhesive Coloplast Ostomy Rod Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Soft-Hold Biatain Silicone Biatain Silicone Lite Biatain Silicone Non-Border Brava Protective Sheets Band-Aid Neutrogena Sensitive Skin Blemish Patches Biatain Silicone Fit Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Mederma Compeed Comfeel Plus Biatain Adhesive Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Biatain Super Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches SpeediCath Compact Set male SpeediCath Standard SpeediCath Standard with Accessories Luja Female

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)