BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MT.DERM GmbH

    Reg #: 3006634874 · FEI: 3006634874 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MT.DERM GmbH
    Registration Number
    3006634874
    FEI Number
    3006634874
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Blohmstrasse 37-61
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180778

    Owner / Operator

    Firm Name
    MT.DERM GmbH
    Operator Number
    10058532
    Address
    Blohmstrasse 37 - 61
    City
    Berlin
    State
    DE-BE
    Postal Code
    12307
    Country
    DE
    Correspondent
    Jan Tentrop

    US Agent

    Business Name
    BioSkin Aesthetics Inc (BioSkin America Inc.)
    Contact Name
    David Burke
    Address
    3100 NW Boca Raton FL #407 Boca Raton
    City
    Boca Raton
    State
    FL
    ZIP
    33431
    Country
    US
    Email
    [email protected]
    Phone
    561 7041882

    Products

    Device Name Product Code
    Powered Microneedle Device QAI

    Proprietary Names

    Footswitch 6-MNP 1.5 Exceed US 6-MNP 1.5 ToskaniMED US Bio Touch Precision Bio Touch Aero 6-MNP 1.5 Exceed II 3 Exceed Unlimited 6-MNP 1.5 Exceed II 2

    Establishment Types

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