BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HAI LABORATORIES, INC.

    Reg #: 1226587 · FEI: 3003046678 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    62
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    HAI LABORATORIES, INC.
    Registration Number
    1226587
    FEI Number
    3003046678
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    320 Massachusetts Ave
    City
    LEXINGTON
    State
    MA
    ZIP
    02420
    Country
    US

    Regulatory Submissions

    510(k) Number
    K994340

    Owner / Operator

    Firm Name
    HAI LABORATORIES, INC.
    Operator Number
    9040002
    Address
    320 MASSACHUSETTS AVE., --
    City
    Lexington
    State
    MA
    Postal Code
    02420
    Country
    US
    Correspondent
    VIVIAN - XUE

    Products

    Device Name Product Code
    Ophthalmoscope, Ac-Powered HLI
    Hook, Ophthalmic HNQ
    Caliper, Ophthalmic HOE
    Cannula, Ophthalmic HMX
    Scissors, Ophthalmic HNF
    Trephine, Manual, Ophthalmic HRH
    Specula, Ophthalmic HNC
    Forceps, Ophthalmic HNR
    Spatula, Ophthalmic HND
    Knife, Ophthalmic HNN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Spoon, Ophthalmic HNB

    Proprietary Names

    EB-3000xyz CL-1000eva CL-1000xyz CL-1000nc Eyelid Retractor Capsule Hook Iris Hook Lens Manipulator Strabismus Hook Lens Nucleus Hook IOL Orientation Hook Castroviejo Caliper Irrigation/Aspiration Cannula Needle Scissors Strabismus Scissors Corneal Scissors Ophthalmic Scissors Iris Scissors Tenotomy Scissors Vannas Scissors Enucleation Scissors Scleral Scissors Cataract Scissors Ophthalmic Trephine Cornea Marker Eye Speculum Pediatric Speculum Strabismus Forceps Tying Forceps Penetration Forceps Micro-needle Holder Capsulorhexis Forceps Capsulotomy Forceps IOL Implantation Forceps Corneal Epidermic Forceps Iris Forceps Hemostat Forceps Corneal Scleral Forceps Fixation Forceps Dressing Forceps Suturing Forceps Chalazion Forceps Trachoma Forceps Cilia Forceps Micro-ophthalmic Forceps Corneal Spatula Iris Spatula Cataract Knife Goniotomy Knife Scleral Dissection Knife Dissection Knife Cystotome Knife AB-6100 AB-6200 SL-5000e SL-5000h SL-5000b SL-5000s SL-5000p Chalazion Curette Eyeball Spoon Lens Spoon

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device