BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TeleMed Systems

    Reg #: 1222168 · FEI: 1222168 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    TeleMed Systems
    Registration Number
    1222168
    FEI Number
    1222168
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    44 Bearfoot Rd Ste 200
    City
    Northborough
    State
    MA
    ZIP
    01532
    Country
    US

    Regulatory Submissions

    510(k) Number
    K901429

    Owner / Operator

    Firm Name
    SHENT USA, INC.
    Operator Number
    10078923
    Address
    8 Kane Industrial Drive
    City
    Hudson
    State
    MA
    Postal Code
    01749
    Country
    US
    Correspondent
    Hanbin Suh

    Products

    Device Name Product Code
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Dislodger, Stone, Biliary LQR
    Snare, Flexible FDI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Accessories, Cleaning Brushes, For Endoscope MNL
    Dilator, Esophageal KNQ
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Endoscopic Cytology Brush FDX
    Needle, Aspiration And Injection, Disposable GAA
    Forceps, Wire Holding HYA
    Forceps, Biopsy, Electric KGE
    Catheter, Irrigation GBX
    Instrument, Biopsy KNW
    Bulb, Inflation, For Endoscope FCY
    Catheter, Balloon Type GBA
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Accessories, Cleaning, For Endoscope FEB
    Tubes, Gastrointestinal (And Accessories) KNT
    Endoscopic Bite Block MNK
    Forceps, Biopsy, Non-Electric FCL

    Proprietary Names

    Guide Wires, "J" & Straight Duralon Occl. Balloon, 2 lumen Retrieval Devices Duralon Occl. Balloon, 3 lumen Sure-flex Balloon Dilatation Cath. Heiss-Device, Endoscopic Scissors Bronchial Cytology Brush ERCP Cannulas Transbronchial Needle Polypectomy Snares DISPOSABLE GRASPING FORCEPS Hot Biopsy Forceps G.I. Cytology Brush Carr-locke, forceps, retriever Biopsy Forceps OCCLUSION BALLOONS DISPOSABLE RETRIEVAL BASKET Sureflex Biliary Balloon Dilatation Sclerotherapy Needle Squeeky Clean Endoscopic Brush PPD Pressure Dilators

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility