BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUANOVATE TECH INC.

    Reg #: 3013501873 · FEI: 3013501873 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    QUANOVATE TECH INC.
    Registration Number
    3013501873
    FEI Number
    3013501873
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    111 Deerwood Rd Ste 200
    City
    San Ramon
    State
    CA
    ZIP
    94583
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181551

    Owner / Operator

    Firm Name
    Quanovate Tech Inc.
    Operator Number
    10054431
    Address
    111 Deerwood Road, Suite 200
    City
    San Ramon
    State
    CA
    Postal Code
    94583
    Country
    US
    Correspondent
    Zheng Yang

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Immunoassay, Pregnanediol Glucuronide, Over The Counter QKE
    Device, Fertility Diagnostic, Proceptive LHD
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA

    Proprietary Names

    Mira Pregnancy Test Mira Ultra4 Wand Mira Plus Wand Mira Max Wand Mira Confirm Wand Mira Basal Body Thermometer Mira Ovum Wand

    Establishment Types

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