Contract manufacturerADROIT MEDICAL SYSTEMS, INC. (Loudon, TN)TennesseeCardiovascularRadiologyGeneral and plastic surgeryClass II
ADROIT MEDICAL SYSTEMS, INC.
Contract manufacturer · Loudon, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1055823 (openFDA record; or search FDA's registration database)
- FEI number
- 1000111140
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- ADROIT MEDICAL SYSTEMS, INC. (FDA owner/operator no. 9005173)
- Registered address
- 1146 CARDING MACHINE RD., Loudon, TN 37774
- Contract listings
- 3 device listings, 3 product codes, first listed Aug 27, 2013
- 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 |
|---|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | Contract manufacturing | Aug 27, 2013 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Jul 11, 2017 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract manufacturing | Apr 2, 2019 |