BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CYTRELLIS BIOSYSTEMS, INC.

    Reg #: 3020704367 · FEI: 3020704367 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    CYTRELLIS BIOSYSTEMS, INC.
    Registration Number
    3020704367
    FEI Number
    3020704367
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    34 Commerce Way
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202517

    Owner / Operator

    Firm Name
    Cytrellis Biosystems, Inc.
    Operator Number
    10082569
    Address
    34 Commerce Way
    City
    Woburn
    State
    MA
    Postal Code
    01801
    Country
    US
    Correspondent
    Robert Hinz

    Products

    Device Name Product Code
    Powered Microneedle Device QAI

    Proprietary Names

    Ellacor(R) System with Micro-Coring(TM) Technology

    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