BEUDAMED
    FDA Registration Active 🇮🇳 India

    SPEEDWAY

    Reg #: 3006550126 · FEI: 3006550126 · Expires 2026
    View on FDA
    Products
    69
    Proprietary Names
    71
    Establishment Types
    2
    Classifications
    69

    Registration Details

    Registration Name
    SPEEDWAY
    Registration Number
    3006550126
    FEI Number
    3006550126
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    A-67/5 G.T Karnal Road Industrial Area, Delhi
    City
    India Delhi
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K945541

    Owner / Operator

    Firm Name
    Speedway Surgical Co.
    Operator Number
    10028319
    Address
    A-67/5 GT Karnal Road Industrial Area, Delhi
    City
    India
    State
    Delhi
    Postal Code
    110033
    Country
    IN
    Correspondent
    Jatin Pahwa

    Products

    Device Name Product Code
    Ophthalmoscopes, Replacement Batteries, Hand-Held MSG
    Cannula, Trocar, Ophthalmic NGY
    Retractor, Ophthalmic HNI
    Probe, Lachrymal HNL
    Depressor, Orbital HNX
    Tonometer, Manual HKY
    Scissors, Ophthalmic HNF
    Clip, Lens, Trial, Ophthalmic HPB
    Chair, Ophthalmic, Ac-Powered HME
    Conformer, Ophthalmic HQN
    Table, Instrument, Powered, Ophthalmic HRJ
    Curette, Ophthalmic HNZ
    Elevator HTE
    Tester, Color Vision HIT
    Prosthesis, Eyelid Spacer/Graft, Polymer QWU
    Prism, Bar, Ophthalmic HKW
    Cap, Surgical FYF
    Spatula, Ophthalmic HND
    Unit, Electrolysis, Battery-Powered, Ophthalmic HPY
    Tray, Surgical, Instrument FSM
    Trephine, Manual, Ophthalmic HRH
    Ring, Ophthalmic (Flieringa) HNH
    Drape, Patient, Ophthalmic HMT
    Chair, Ophthalmic, Manual HMD
    Clamp, Eyelid, Ophthalmic HOD
    Stand, Instrument, Ophthalmic, Battery Powered NOI
    Loupe, Diagnostic/Surgical FSP
    Punch, Corneo-Scleral HNJ
    Forceps, Ophthalmic HNR
    Hook, Ophthalmic HNQ
    Strip, Schirmer KYD
    Spud, Ophthalmic HNA
    Ophthalmoscope, Battery-Powered HLJ
    Needle, Ophthalmic Suturing HNM
    Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal MXY
    Cannula, Ophthalmic HMX
    Gown, Examination FME
    Biomicroscope, Slit-Lamp, Ac-Powered, Exempt PUE
    Disinfectant, Medical Devices LRJ
    Marker, Ocular HMR
    Expressor HNS
    Gauge, Lens, Ophthalmic HLN
    Loupe, Binocular, Low Power HJH
    Set, Lens, Trial, Ophthalmic HPC
    Dilator, Lachrymal HNW
    Burr, Corneal, Battery Powered, Rust Ring Removal OHW
    Table, Instrument, Manual, Ophthalmic HRK
    Shoe And Shoe Cover, Conductive BWP
    Device, Measuring, Lens Radius, Ophthalmic HLF
    Exophthalmometer HLS
    Trocar, Ent KTE
    Shell, Scleral HQT
    Tape And Bandage, Adhesive KGX
    Lens, Condensing, Diagnostic HJL
    Prism, Fresnel, Ophthalmic HKT
    Spoon, Ophthalmic HNB
    Clamp, Muscle, Ophthalmic HOB
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Sunglasses (Non-Prescription Including Photosensitive) HQY
    Specula, Ophthalmic HNC
    Caliper, Ophthalmic HOE
    Knife, Ophthalmic HNN
    Mirror, Headband, Ophthalmic HKF
    Handle, Instrument, Dental EJB
    Depressor, Metal Tongue, Surgical KBL
    Cover, Cast KIA
    Frame, Trial, Ophthalmic HPA
    Spectacle, Operating (Loupe), Ophthalmic HOH
    Cable ISN

    Proprietary Names

    Indirect Ophthalmoscope wireless trocar system Ophthalmic retractors Lacrimal Probes, lacrimal intubation set depressor tonometer Eye scissors, westcott, corneal, vannas, stevens, iris, knapp, others Trial Lens Ophthalmic chair Eye conformer instrument table motorised Ophthalmic curette, chalzion curette eye elevator color vision test Artificial eyes Prism bar surgical cap Ophthalmic spatulas Diathermy machine plastic tray, steel tray , sterilization tray Corneal trephine Ophthalmic rings eye drape, patient drape Ophthalmic chair manual ophthalmic clamps Instrument Table, stand Diagnostic lenses Kelly's punch, corneal punch Ophthalmic Forceps, suture tying, corneal, others Curette Hooks, Choppers, Picks, Manipulators diagnostic strips spud Needle Holder, Ophthalmic needles cannula irrigation/aspiration, IA handpiece trocar cannula cannula irrigation/aspiration surgical gown, examination gown Slit Lamp medical disinfectant eye markers Expressor, Meibomian Expressor Opthalmic gauge Eye Loupe Trial Lens set Lacrimal dilator, castroveijo dilator Alger Brush instrument table manual ophthalmic cannula shoe cover Markers and calipers exophthalmometer trocar corneal shield protector surgical tape, bandage ophthalmic prisms spoon Muscle clamps, hooks shield after cataract galsses Eye Speculums, wire speculums, leiberman speculums, screw speculums Braunstein caliper, castroveijo caliper Ophthalmic knives, saphire knives ophthalmic headband handle, instrument scleral depressors Electro cautery instrument cover Trial frame, lens operating loupe, optical loupe Bipolar Cable

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device