Contract manufacturerGENYSYS 22, LLC (Warsaw, IN)IndianaGeneral and plastic surgeryClass I
GENYSYS 22, LLC
Contract manufacturer ยท Warsaw, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003740112 (openFDA record; or search FDA's registration database)
- FEI number
- 3003740112
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Genysys 22, LLC (FDA owner/operator no. 10094155)
- Registered address
- 2466 N 200 W, Warsaw, IN 46580
- Contract listings
- 3 device listings, 3 product codes, first listed Nov 18, 2025
- 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 |
|---|---|---|---|---|---|
| GFI | Osteotome, Manual | Class I | General and plastic surgery | Contract manufacturing | Nov 18, 2025 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract manufacturing | Nov 18, 2025 |
| KDG | Chisel (Osteotome) | Class I | General and plastic surgery | Contract manufacturing | Nov 18, 2025 |