BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    BLUE.S4

    Reg #: 3005405896 · FEI: 3005405896 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    36
    Establishment Types
    3
    Classifications
    6

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    Registration Details

    Registration Name
    BLUE.S4
    Registration Number
    3005405896
    FEI Number
    3005405896
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    269 University Ave
    City
    Belleville Ontario
    Country
    CA

    Owner / Operator

    Firm Name
    Blue.S4
    Operator Number
    9078622
    Address
    269 University Ave, --
    City
    Belleville
    State
    Ontario
    Postal Code
    K8N 5S3
    Country
    CA
    Correspondent
    Mary Anne - Bembridge

    US Agent

    Business Name
    Sunbreak Investments, LLC dba Vision28
    Contact Name
    Rich Wynkoop
    Address
    915 Sw Rimrock Way Ste 201-402
    City
    Redmond
    State
    OR
    ZIP
    97756
    Country
    US
    Email
    [email protected]
    Phone
    541 6049654

    Products

    Device Name Product Code
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Table, Instrument, Powered, Ophthalmic HRJ
    Chair, Ophthalmic, Ac-Powered HME
    Pupillometer, Manual HLH
    Stool, Operating-Room FZM
    Stand, Instrument, Ac-Powered, Ophthalmic HMF

    Proprietary Names

    RT-600-LN-BLK RT-600-LN-GRY RT-600-LP-BLK RT-600-SP-BLK RT-600-SN-BLK RT-600-SN-GRY Instrument table - Atlas Pedestal 230V H-Base Table 2-UP with controller and line-voltage outlets Instrument table - Atlas Pedestal H-Base Table 2_UP lx with controller and line-voltage outlets Phantom Table - 240V Phantom Table - 120V Table 3-UP with controller and line-voltage outlets Instrument table - Atlas wheelchair Pedestal 230V U-Base Instrument table - Atlas wheelchair Pedestal U-Base S4OPTIK Examination Chair - Model 1800-CH-H S4OPTIK Combination Chair & Stand - Model 2000-CB-H S4OPTIK Combination Chair & Stand - Model 2500-CB-H S4OPTIK Examination Chair - Model 2500-CH-H S4OPTIK Combination Chair & Stand - Model 1800-CB-H Lombart CS6 Chair - Model CS-6-CH-H S4OPTIK Examination Chair & Stand - Model 1000-CB-H Marco Bravo 2 Chair - Model BR2-CH-H S4OPTIK Combination Chair & Stand - Model 2000-CB-H-L S4OPTIK Chair Model 1000-CH-H S4OPTIK Examination Chair - Model 2000-CH-H S4OPTIK Combination Chair & Stand - Model 2500-CB-H-L PD-1-S4 PD-1 S4OPTIK Exam Stool with backrest S4OPTIK Exam Stool without backrest S4OPTIK INSTRUMENT STAND - MODEL 1600-ST S4OPTIK INSTRUMENT STAND - MODEL 2000-ST Lombart CS6 STAND - Model CS-6-ST Marco Bravo 2 Stand-Model BR2-ST S4OPTIK POWERED STOOL - MODEL 9000

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)