BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    KardiaMobile System

    Reg #: 3015134086 · FEI: 3015134086 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TECAN CDMO SOLUTIONS PN SDN. BHD.
    Registration Number
    3015134086
    FEI Number
    3015134086
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PMT1199 (Plot 372), Penang Science Park, Lorong Perindustrian Bukit Minyak 21, Taman Perindustrian, Bukit Minyak, 14100 Simpang Ampat, Seberang Perai Tengah,
    City
    Penang Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K182396

    Owner / Operator

    Firm Name
    Tecan Group AG
    Operator Number
    9050992
    Address
    103 Seestrasse, --
    City
    Maennedorf
    State
    Zurich
    Postal Code
    8708
    Country
    CH

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    KardiaMobile System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)