BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    INNOCARE OPTOELECTRONICS CORP.

    Reg #: 3015531968 · FEI: 3015531968 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INNOCARE OPTOELECTRONICS CORP.
    Registration Number
    3015531968
    FEI Number
    3015531968
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C.
    City
    Tainan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K250211

    Owner / Operator

    Firm Name
    InnoCare Optoelectronics Corp.
    Operator Number
    10060738
    Address
    Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C.
    City
    Tainan
    State
    TW-TNN
    Postal Code
    741
    Country
    TW
    Correspondent
    Eason Tsai

    US Agent

    Business Name
    InnoCare Optoelectonics USA, Inc
    Contact Name
    Iris Lin
    Address
    101 METRO DRIVE SUITE 365
    City
    San Jose
    State
    CA
    ZIP
    95110
    Country
    US
    Email
    [email protected]
    Phone
    408 6412700

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Enduro DR Yushan Flat Panel Detector with Xresta+iOS REMEX RD RXSensor Yushan X-Ray Flat Panel Detector (Model name: V14C IN, F14C IN, V17C IN, V17Ce IN) Reveal 35C Yushan Flat Panel Detector (flexible) ENDURO DR Yushan X-Ray Flat Panel Detector (Model name: F14C IN) Yushan Flat Panel Detector with DROC Yushan X-Ray Flat Panel Detector (Model name: V14C IN, V17C IN)

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)