FDA Registration
Active
🇺🇸 United States
MENDTRONIX, INC.
Reg #: 3010844918
·
FEI: 3010844918
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- MENDTRONIX, INC.
- Registration Number
- 3010844918
- FEI Number
- 3010844918
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1855 Dornoch Court, Suite 100
- City
- San Diego
- State
- CA
- ZIP
- 92154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231424
Owner / Operator
- Firm Name
- Mendtronix Inc.
- Operator Number
- 10053335
- Address
- 1855 Dornoch Court, Suite 100
- City
- San Diego
- State
- CA
- Postal Code
- 92154
- Country
- US
- Correspondent
- Michael Ritter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2022-12-14 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2026-05-27 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2024-05-07 |
| Chamber, Patient Isolation | LGM | Class 2 | General Hospital | No | 2025-04-30 |
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2022-06-08 |
Proprietary Names
Multiphze Enclosed Bladder Irrigation System - includes urinary drainage bag and drape
HeartBeam AIMIGo System; HeartBeam System
Burble
Carecube Negative Pressure Isolation Chamber
BioImp Body Composition Analyzer; SOZO system; SOZOapp with SOZOpro measurement module; SOZOhub database
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)