BEUDAMED
    EU Manufacturer 🇹🇼 Taiwan Active

    Rolence Enterprise Inc.

    SRN: TW-MF-000024483 · Pu Chung Rd. 18-3, 32083 Taoyuan, Taiwan
    View on EUDAMED
    Basic UDI-DIs
    14
    Total Devices
    16
    On Market
    16
    Off Market
    0
    Certificates
    2
    Valid
    0
    Expiring < 6mo
    0
    Countries
    6

    Basic Information

    Address
    Pu Chung Rd. 18-3, 32083 Taoyuan, Taiwan
    Email
    [email protected]
    Phone
    +88634631999
    Website
    http://www.rolence.com.tw/

    Regulatory Overview

    Regulation
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    Eu Mdd 11
    Eu Mdr 3
    Classification
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    Eu Md Class 2a 9
    Eu Md Class 1 3
    Eu Md Class 2b 2
    Device Types
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    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 1434-MDD-136/2021 May 27, 2024
    MDD Annex II (excluding section 4) 1434-MDD-135/2021 May 27, 2024

    Market Presence

    Devices from this manufacturer are available in 6 countries across Europe.

    🇩🇪 Germany 🇪🇸 Spain 🇭🇷 Croatia 🇮🇪 Ireland 🇮🇹 Italy 🇹🇷 Türkiye

    Device Portfolio

    Name
    Dental Curing Light
    Dental Curing Light
    Dental Curing Light 1000E
    Dental Curing Light 1800E
    Dental Curing Light Q6-NLG
    Protable X-Ray XR-01
    Sensor RXS 1000
    Ultrasonic Scaler MS-1/MS-1 Dual
    Ultrasonic Scaler MS-10
    Ultrasonic Scaler MS-10B
    Ultrasonic Scaler MS-30
    Ultrasonic Scaler MS-50
    Ultrasonic Scaler PS-1/PS-1 Dual
    Ultrasonic Scaler PS-25
    Ultrasonic Scaler PS-25B
    Ultrasonic Scaler PS-30