BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GURIN PRODUCTS LLC

    Reg #: 3006793151 · FEI: 3006793151 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GURIN PRODUCTS LLC
    Registration Number
    3006793151
    FEI Number
    3006793151
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2522 Chambers Rd Ste 100
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130947

    Owner / Operator

    Firm Name
    Gurin Products, LLC
    Operator Number
    10031258
    Address
    2522 Chambers Rd, Suite 100
    City
    Tustin
    State
    CA
    Postal Code
    92780
    Country
    US
    Correspondent
    Sanjay Gupta

    Products

    Device Name Product Code
    Oximeter, Infrared, Sporting, Aviation OCH
    Oximeter DQA
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Blood Pressure Cuff DXQ

    Proprietary Names

    GURIN SANTAMEDICAL SM-165 SANTAMEDICAL SM-110 GURIN GO-410 SM-150Y SANTAMEDICAL SM-150 SANTAMEDICAL SM-165-S SM-1100S SM-110 SM-240 SM-150BL SM-230 SM-150G SM110OS SM-1100P SM-165-S SM-165 GO-410 SM-1100B JPD-500E SM-519BR-BL SM110OBL SM110OB SM110OP 2F3133 AccuraPulse AP-WBPM810 TMB-1580 SPS-120 SP-110ND SPR-210B SPR-210P

    Establishment Types

    Repack or Relabel Medical Device