BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SurePulse VS Cap

    Reg #: 3018685978 · FEI: 3018685978 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SUREPULSE MEDICAL LIMITED
    Registration Number
    3018685978
    FEI Number
    3018685978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Medicity D6 Thane Road
    City
    Nottingham Nottinghamshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K201887

    Owner / Operator

    Firm Name
    SurePulse Medical Limited
    Operator Number
    10084383
    Address
    Medicity D6 Thane Road
    City
    Nottingham
    State
    Nottinghamshire
    Postal Code
    NG90 6BH
    Country
    GB
    Correspondent
    James E Carpenter

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    SurePulse VS Cap SurePulse VS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device