BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    INNOVA MEDICAL OPHTHALMICS

    Reg #: 3015972897 · FEI: 3015972897 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    25

    Registration Details

    Registration Name
    INNOVA MEDICAL OPHTHALMICS
    Registration Number
    3015972897
    FEI Number
    3015972897
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    136 Sparks Avenue
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K022054

    Owner / Operator

    Firm Name
    Innova Medical Ophthalmics
    Operator Number
    10062378
    Address
    136 Sparks Avenue
    City
    Toronto
    State
    Ontario
    Postal Code
    M2H 2S4
    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
    Forceps, Ophthalmic HNR
    Keratoscope, Ac-Powered HLQ
    Dilator, Lachrymal HNW
    Tonometer, Manual HKY
    Burr, Corneal, Battery-Powered HOG
    Refractometer, Ophthalmic HKO
    Projector, Ophthalmic HOS
    Specula, Ophthalmic HNC
    Cannula, Ophthalmic HMX
    Depressor, Orbital HNX
    Chart, Visual Acuity HOX
    Chair, Ophthalmic, Ac-Powered HME
    Camera, Ophthalmic, Ac-Powered HKI
    Spud, Ophthalmic HNA
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Topographer, Corneal, Ac-Powered MMQ
    Pupillometer, Ac-Powered HLG
    Rack, Skiascopic HMH
    Pupillometer, Manual HLH
    Table, Instrument, Powered, Ophthalmic HRJ
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Prism, Fresnel, Ophthalmic HKT
    Tester, Color Vision HIT
    Retractor, Ophthalmic HNI

    Proprietary Names

    REMOTE VISION RV-II S4OPTIK REFRACTOR MODEL SL-Y100 TEUFEL - BARRAQUER CILIA FORCEPS SIRIUS S4Optik JAVAL Ophthalmometer MODI' 02 KERATOMETER; Model K-1 TEUFEL - CASTROVEIJO LACRIMAL DILATOR TONOMETER – MODEL F900 TONOMETER – MODEL A900 Amoils Epithelial Scrubber Hand Held Auto Refractometer Retinomax 5 Hand Held Auto Refractometer Retinomax Screeen Hand Held Auto Refract-Keratometer Retinomax K-plus5 Hand Held Auto Refract-Keratometer Retinomax K+Screeen CP-2033 CHART PROJECTOR TEUFEL - BARRAQUER WIRE SPECULUM TEUFEL - ANEL CANNULA LACRIMAL Tonometer, Z800 KEELER SCLERAL DEPRESSOR - PENCIL TYPE VA-1 S4OPTIK Combination Chair & Stand - Model 1000-CB S4OPTIK Combination Chair & Stand - Model 2000-CB S4OPTIK Combination Chair & Stand - Model 2500-CB S4OPTIK Examination Chair - Model 2000-CH Stamina™ Tilt Chair S4OPTIK Combination Chair & Stand - Model 1800-CB S4OPTIK Examination Chair - Model 1000-CH S4OPTIK Examination Chair - Model 1800-CH S4OPTIK Examination Chair - Model 2500-CH FUNDUS/RETINAL CAMERA - COBRA GOLF CLUB SPUD LAFORCE LED Slit Lamp MW50D Zoom Slit Lamp NS-2D with options RS-1000 ZOOM SLITLAMP WITH OPTION S4OPTIK ANTARES TOPOGRAPHER S4OPTIK PUPILOMETER - DIGITA RETINOSCOPY RACK - L2 PUPILOMETER Model PD-1 2 - UP S4OPTIK,SL-H2,SL-H3,SL-H5,SL-HZ,SL-Z2,SL-Z3,SL-Z5,SL-ZZ Stamina™ Ophthalmic Stand S4OPTIK INSTRUMENT STAND - MODEL 1600-ST S4OPTIK INSTRUMENT STAND - MODEL 2000-ST 3M PRESS ON FRESNEL PRISM ISHIHARA 14 PLATE COLOUR TEST TEUFEL - DESMARRES RETRACTOR LID

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device