FDA Registration
Active
🇲🇽 Mexico
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)
Reg #: 3016674095
·
FEI: 3016674095
·
Expires 2026
Products
21
Proprietary Names
29
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- Industrial Vallera de Mexicali, S.A. de C.V. (Terra)
- Registration Number
- 3016674095
- FEI Number
- 3016674095
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carretera Mexicali-Algodones # 4798 Int. 4-1, Col. Diez Division Dos
- City
- Mexicali Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K223721
Owner / Operator
- Firm Name
- MASIMO CORPORATION
- Operator Number
- 9031881
- Address
- 52 Discovery, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Mathew Jimenez
US Agent
- Business Name
- Masimo Corporation
- Contact Name
- Mathew Jimenez
- Address
- 52 Discovery
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 2977558
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-01-23 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-01-23 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2020-08-03 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-08-03 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2020-08-03 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2022-03-22 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-03-22 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-03-22 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2022-03-22 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2022-03-22 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-05-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-05-14 |
| Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | JKS | Class 1 | Clinical Toxicology | No | 2021-05-14 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2023-06-05 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2023-06-05 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-06-05 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-06-05 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2023-06-05 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2023-06-05 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2023-06-05 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-06-05 |
Proprietary Names
Stork Hub
Stork Vitals
Stork Sensor
Stork Vitals+
Root
Centroid
SedLine Sensors
SedLine Module
RD SedLine Sensors
RD SET Multisite Reusable sensors
RD Speciality sensors
RD SET Reusable sensors
RD SET Disposable sensors
RD SET Neo
Radius VSM and Accessories
Radius VSM RAS-45
Rad-57
LNCS-II rainbow DCI 8 Lambda
rainbow DCI
rainbow DCI SC
RD SET CS Disposable Sensors
LNCS Disposable Sensors
M-LNCS Disposable Sensors
Masimo SET Rad 57 cm Pulse CO-Oximeter
Masimo SET Rad 57 m Pulse CO-Oximeter
Masimo SET Red reusable sensors
rainbow DCI-mini
Rad-67
Radius-7
Establishment Types
Manufacture Medical Device