BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SHAHAK-TEC LTD.

    Reg #: 3010223399 · FEI: 3010223399 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    SHAHAK-TEC LTD.
    Registration Number
    3010223399
    FEI Number
    3010223399
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1, Avshalom Road, POB 166
    City
    Zichron Yaakov Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K011536

    Owner / Operator

    Firm Name
    Shahak-Tec Ltd.
    Operator Number
    10042902
    Address
    1, AvShalom Road, POB 166
    City
    Zichron Yaakov
    State
    IL-NOTA
    Postal Code
    3095101
    Country
    IL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Lubricant, Patient KMJ
    Drain, Tee (Water Trap) BYH
    Gas, Collecting Vessel KGK

    Proprietary Names

    Smart CapnoLine Plus H O2 Smart CapnoLine O2 Pediatric Smart CapnoLine Plus O2 LONG Smart CapnoLine Plus O2 Smart CapnoLine Guardian Smart CapnoLine Guardian LONG CAPNOLINE H O2 ADULT Smart SureLine Plus O2 Watertrap Breath Collection Kit Sure VentLine Set FilterLine Set, Adult Pediatric FilterLine H Set, Adult/Pediatric Sure VentLine H Set VitaLine H Set, Adult Pediatric FilterLine Set, Infant/Neonate

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device