BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CloudCath Peritoneal Dialysis Drain Set Monitoring System

    Reg #: 3003537036 · FEI: 3003537036 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TECAN CDMO SOLUTIONS MH, CORP.
    Registration Number
    3003537036
    FEI Number
    3003537036
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18735 MADRONE PKWY.
    City
    MORGAN HILL
    State
    CA
    ZIP
    95037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212658

    Owner / Operator

    Firm Name
    Tecan Group AG
    Operator Number
    9050992
    Address
    103 Seestrasse, --
    City
    Maennedorf
    State
    Zurich
    Postal Code
    8708
    Country
    CH

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    CloudCath Peritoneal Dialysis Drain Set Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)