BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Dilapan-S

    Reg #: 3003994796 · FEI: 1000573518 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Medicem Technology s.r.o
    Registration Number
    3003994796
    FEI Number
    1000573518
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Karlovarska trida 20
    City
    Kamenne Zehrovice Stredocesky Kraj
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K143447

    Owner / Operator

    Firm Name
    MEDICEM Technology
    Operator Number
    9041858
    Address
    KARLOVARSKA TRIDA 20, --
    City
    KAMENNE ZEHROVICE
    State
    Stredocesky Kraj
    Postal Code
    273 01
    Country
    CZ
    Correspondent
    Jana - Subrtova

    US Agent

    Business Name
    Medicem Inc.
    Contact Name
    Susanne Parks
    Address
    125 High Street, Suite 1704
    City
    Boston
    State
    MA
    ZIP
    02110
    Country
    US
    Email
    [email protected]
    Phone
    862 2680960

    Products

    Device Name Product Code
    Dilator, Cervical, Synthetic, Osmotic PKN

    Proprietary Names

    Dilapan-S

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device