Contract manufacturerMENDTRONIX, INC. (San Diego, CA)CaliforniaEar, nose and throatGastroenterology and urologyGeneral hospitalClass IClass II
MENDTRONIX, INC.
Contract manufacturer · San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010844918 (openFDA record; or search FDA's registration database)
- FEI number
- 3010844918
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- Mendtronix Inc. (FDA owner/operator no. 10053335)
- Registered address
- 1855 Dornoch Court, Suite 100, San Diego, CA 92154
- Contract listings
- 3 device listings, 3 product codes, first listed Dec 14, 2022
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| KAR | Irrigator, Sinus | Class I | Ear, nose and throat | Contract manufacturing | May 7, 2024 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Class II | Gastroenterology and urology | Contract manufacturing | Dec 14, 2022 |
| LGM | Chamber, Patient Isolation | Class II | General hospital | Contract manufacturing | Apr 30, 2025 |