BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HAMILTON THORNE, Inc.

    Reg #: 1221433 · FEI: 1221433 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    84
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    HAMILTON THORNE, Inc.
    Registration Number
    1221433
    FEI Number
    1221433
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    100 CUMMINGS CENTER-SUITE 465E
    City
    Beverly
    State
    MA
    ZIP
    01915
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202089

    Owner / Operator

    Firm Name
    Hamilton Thorne, Inc.
    Operator Number
    1221433
    Address
    100 Cummings Center, Suite 465E
    City
    Beverly
    State
    MA
    Postal Code
    01915
    Country
    US
    Correspondent
    Nicole M Thibodeau

    Products

    Device Name Product Code
    Semen Analysis Device POV
    Labware, Assisted Reproduction, Exempt PUD
    Media, Reproductive MQL
    System, Assisted Reproduction Laser MRX
    Wright'S Stain IAF
    Media, Reproductive, Exempt QKI
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Catheter, Assisted Reproduction MQF
    Labware, Assisted Reproduction MQK
    Microscope And Microscope Accessories, Reproduction, Assisted MTX
    Accessory, Assisted Reproduction MQG
    Counter, Differential Cell GKZ
    Counter, Cell, Automated (Particle Counter) GKL
    Micromanipulators And Microinjectors, Assisted Reproduction MQJ
    Research Use Only/Hematology Devices OTQ
    Accessory, Assisted Reproduction, Exempt PUB
    Material, Quality Control, Semen Analysis NRF

    Proprietary Names

    LensHooke X1 PRO SE Semen Quality Analyzer 4-Chamber Analysis Slide GM501 VitriStore Freeze Kit GM501 VitriStore Thaw Kit LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS) GM501 Gradient 100% GM501 Gradient 90% GM501 Gradient 45% GM501 SpermStore LensHooke Sperm DNA Fragmentation Test Kit Gems Sperm Buffer Gems Sperm Medium Gems Sperm Wash Gradient Set (45% And 90%) GM501 SpermMobil GM508 CultActive Sterica 210/270 Javica 120/150 Unica Classica 180 Classica 150 Javica 210 Sterica 120 Javica 180 Javica 240 Classica 120 Sterica 180 Econica 120 Sterica 90 Sterica 150 Econica 60 Classica 90 Gynemed Assisted Reproduction Microtools Gynemed Holding Pipette Gynemed ICSI Gynemed Biopsy Pipette Gynemed Gynemed Microtools GM501 Wash with Phenolred and Gentamicin (PRG) #2000 Semtrac Set 5 #4219 Emtrac Set #4000 Tulip #4219 Emtrac Delphin #4219 Emtrac A Geri Water Bottle Geri Dish Geri Embryo Incubator Gems Fertilisation Medium Gems Blastocyst Medium Gems VitBase Gems Cleavage Medium Gems Geri Medium LensHooke C-KUP Liquefaction Test Cup LensHooke Semen Test Cassette LensHooke X1 Pro Semen Quality Analyzer LensHooke Liquefaction Test Cup LensHooke X1 Semen Quality Analyzer LensHooke Semen Quality Analyzer GM501 Mineral Oil Geri Connect Server (including software) Geri Software Connect and Assess Gems Oocyte Retrieval Buffer LYKOS ZILOS-tk #4225 Smooze Long #4220 IUI Memo #4225 Smooze Medium #4220 IUI #4220 Plus #4225 Smooze HELOS IVOS TELOS IVOS II-v14 CEROS GM501 Wash Gems Vitrification Set Gems Warming Set TrakJector TrakJector Micromanipulator LensHooke X12 PRO Semen Analysis System FERTY Syringe Plus GM501 SpermActive GM501 SpermAir accu-beads

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device