BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    TH Oral 249

    Reg #: 3009327445 · FEI: 3009327445 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    62
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SMC Costa Rica Division S.R.L.
    Registration Number
    3009327445
    FEI Number
    3009327445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building B48, Ave 0, Zona Franca Coyol
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K040595

    Owner / Operator

    Firm Name
    SCIENTIFIC MOLDING CORPORATION LTD
    Operator Number
    9057460
    Address
    330 SMC DRIVE, --
    City
    Somerset
    State
    WI
    Postal Code
    54025
    Country
    US

    US Agent

    Business Name
    SCIENTIFIC MOLDING CORPORATION LTD
    Contact Name
    Bryan Moris
    Address
    330 Smc Dr
    City
    Somerset
    State
    WI
    ZIP
    54025
    Country
    US
    Email
    [email protected]
    Phone
    715 2473500

    Products

    Device Name Product Code
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    TH Oral 249 Thermistor Airflow Sensor 1 Body Position Sensor , 249 TH 1 CH P Sandman Express Effort Sensor CT2 Adult AL3 CT2 A Chest Pocket CT2 Piezo Resp Effort Sen Adult Velcro Strap PLM Small Adult Velcro strap 1.5", size 3 AFS 2 CH Adult Cann Style TH 1 CH P Alice PDx GRASS VELCRO STRAP KIT A zRIP Wireset, Medcare PLM Sensor 249 ADULT VELCRO STRAP STRAP KIT 1.5 NK Piezo Sensor Microphone Snore Pocket GRASS Piezo Sensor A Effort Sensor CT2 PED AL3 AF Ther 10K Adult 1 CH 1.5 mm Pediatric Piezo Sensor Strap CT2 Effort Sensor Adult Stardust AFS 1 CH Pediatric Cann Style CT2 Piezo Resp Effort Sen Ped AFS 3 CH Adult Cann Style Effort Sensor CT2 PED AL4 TH 1 CH P Embletta TH 1 CH A Embletta SPI SEN DC W 1.5MM Safety Conn AFS 1 CH Adult Cann Style AL4 Snore Embletta AFS 1 CH Adult Cann Style Adult Velcro strap 1.5", size 1 AF 1 CH A Binder 100cm Body Position Sensor Alice 5 Thermistor Oral Alice PDx Piezo Resp Eff Sen Adlt Buc GRASS Piezo Sensor P Snore Microphone Thermistor Nasal Oral Adult AFS 2 CH Pediatric Cann Style GRASS Velcro Strap Kit Pediatric Snore Microphone 249 Adult Velcro strap 1.5", size 2 AF 1 CH A Binder 125cm PLM Sensor Piezo Sensor 1.5" AF Ther 10K Adult 1 CH 249 WS zRIP Alice 3 SPI Sensor DC Quantum Wireset AF 1 CH P Binder 200cm AF 1 CH P Binder 125cm Thermistor Sensor Adult Stardust TH 1 CH A Sandman Express CT2 A Embletta Thermistor Pediatric 1 CH AL CT Pediatric Velcro strap kit 1" AFS 1 CH Adult Cann Style AL3 Effort Sensor Ct2 Adult AL4 BreathSEN Cable Snore Sensor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)