BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Industrial Vallera de Mexicali, S. A. de C. V.

    Reg #: 3004415095 · FEI: 3004415095 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    113
    Establishment Types
    1
    Classifications
    40

    Registration Details

    Registration Name
    Industrial Vallera de Mexicali, S. A. de C. V.
    Registration Number
    3004415095
    FEI Number
    3004415095
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calzada del Oro no. 2001, Parque Industrial Palaco
    City
    Mexicali Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K121912

    Owner / Operator

    Firm Name
    MASIMO CORPORATION
    Operator Number
    9031881
    Address
    52 Discovery, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Oximeter DQA
    Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use QYU
    Continuous Measurement Thermometer FLL
    Burst Suppression Detection Software For Electroencephalograph ORT
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY
    Index-Generating Electroencephalograph Software OLW
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Oximeter, Ear DPZ
    Oximeter, Tissue Saturation MUD
    Hyperoxia Monitoring Device Adjunct To Pulse Oximetry QWE
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Pulse Oximeter For Over-The-Counter Use OLK
    Medical Device Data System OUG
    Cannula, Nasal, Oxygen CAT
    Full-Montage Standard Electroencephalograph GWQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Oximeter, Reprocessed NLF
    Connector, Airway (Extension) BZA
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Computer, Diagnostic, Programmable DQK
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Blood Pressure Cuff DXQ
    Alarm, Blood-Pressure DSJ
    Monitor, Bed Patient KMI
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Oximeter, Infrared, Sporting, Aviation OCH

    Proprietary Names

    MLNCS E1 LNCS E1 Stork Hub Stork Vitals Stork Vitals+ Stork Sensor LNCS Reprocessed Sterile Sensors SedLine Sensors SedLine Module RD SedLine Sensors RD SET Neo rainbow SpHb Disposable Sensors Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC O3 Sensor O3 Regional Oximetry Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare Radius T RD rainbow Lite SET-1 RD rainbow 4 Lambda RD rainbow SET-2 RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors RD SET TF-I M-LNCS TF-I LNCS TF-I Pronto rainbow DCI-mini Rad-67 MAC Adapter Cable AC-1 Adapter Cable Rainbow ReSposable Sensors Rainbow ReSposable U Sensors SpO2.com Sensors MightySat Medical Masimo SafetyNet LNCS Sterile Sensors MightySat Rx M-LNCS Blue LNCS Blue RD SET TFA-1 M-LNCS TFA-1 LNCS TFA-1 M-LNCS Red TFA-1 Radius-7 Masimo SET Rad 57 cm Pulse CO-Oximeter Masimo SET Rad 57 m Pulse CO-Oximeter Masimo SET Red reusable sensors uSpO2 Cables LNCS YI M-LNCS YI NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module EMMA Airway Adapter Radius PCG EMMA RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors Rad-5v Rad-5 rainbow SpCO Disposable Sensors LNCS-II rainbow 8 Lambda RD rainbow 8 Lambda RD SET DBI DBI-dc LNCS DBI Red DBI M-LNCS DBI M-LNCS Sterile Sensors M-LNCS Reprocessed Sterile Sensors RAS-125 RAS-125c RAS-45 LiDCOunity v2 Hemodynamic Monitor LiDCO Module Red MNC Cable NC Adapter Cable MNC Cable IRMA Airway Adapter IRMA AX+ IRMA CO2 IntelliVue Module Rad-97 Radical Docking Station Radical-7 RAS-45 Neo Radius PPG and Accessories Radius VSM and Accessories Radius VSM RAS-45 Root Centroid Rad-G Sensor Rad-G YI Rad-G Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors iSpO2 MightySat CareScape SpO2 - Masimo rainbow SET IntelliVue Module

    Establishment Types

    Manufacture Medical Device