BEUDAMED
    Authorized Representative 🇵🇱 Poland

    MDR Regulator Sp. z o. o.

    SRN: PL-AR-000002485 · Al. Jerozolimskie 123A, 02-017 Warszawa, Poland
    View on EUDAMED
    Manufacturers
    2
    Devices
    3
    Certificates
    1
    PRRCs
    1

    Basic Information

    Address
    Al. Jerozolimskie 123A, 02-017 Warszawa, Poland
    Email
    [email protected]
    Phone
    +48 731 015 999
    Website
    https://mdrregulator.com/
    VAT Number
    PL5272926228

    Non-EU Manufacturers

    Name
    RFBio Co., Ltd
    BIOPTRON AG

    Manufacturers

    BIOPTRON AG

    Manufacturer
    🇨🇭 Switzerland

    RFBio Co., Ltd

    Manufacturer
    🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Certificates

    Type Number
    MDD Annex II Section 4 1434-MDD-149/2021

    Devices

    dermaren SUB-Q with lidocaine

    Device
    EU MDD · Eu Md Class 3 ·RFBio Co., Ltd·On the market·1 country

    SARDENYA Shape with lidocaine

    Device
    EU MDD · Eu Md Class 3 ·RFBio Co., Ltd·On the market·1 country

    YOUTHFILL Shape with lidocaine

    Device
    EU MDD · Eu Md Class 3 ·RFBio Co., Ltd·On the market·1 country