Contract manufacturerLumitex Medical Devices, Inc. (Brecksville, OH)OhioGastroenterology and urologyDentalClass IClass II
Lumitex Medical Devices, Inc.
Contract manufacturer · Brecksville, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1000122810 (openFDA record; or search FDA's registration database)
- FEI number
- 1000122810
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Lumitex Medical Devices, Inc. (FDA owner/operator no. 9000093)
- Registered address
- 6611 W Snowville Rd, Brecksville, OH 44141
- Contract listings
- 2 device listings, 2 product codes, first listed Dec 16, 1999
- 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 |
|---|---|---|---|---|---|
| FDG | Retractor, Fiberoptic | Class I | Gastroenterology and urology | Contract manufacturing | Dec 16, 1999 |
| SGQ | Intraoral Phototherapy Device | Class II | Dental | Contract manufacturing | Sep 24, 2026 |