Contract manufacturerGENER8 (San Jose, CA)CaliforniaGeneral and plastic surgeryPhysical medicineClass II
GENER8
Contract manufacturer · San Jose, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3012157621 (openFDA record; or search FDA's registration database)
- FEI number
- 3012157621
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Gener8 (FDA owner/operator no. 10059512)
- Registered address
- 2560 Junction Avenue, San Jose, CA 95134
- Contract listings
- 3 device listings, 3 product codes, first listed Jan 30, 2019
- 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 |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract manufacturing | Jan 30, 2019 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | Physical medicine | Contract manufacturing | Jun 29, 2023 |
| QPZ | Contact Cooling For Skin Lesion Pain Relief | Class II | General and plastic surgery | Contract manufacturing | Jun 29, 2023 |