Contract manufacturerGilero, Inc (Pittsboro, NC)North CarolinaGeneral hospitalAnesthesiologyCardiovascularGastroenterology and urologyGeneral and plastic surgeryPhysical medicineClass IIClass IUnclassified
Gilero, Inc
Contract manufacturer ยท Pittsboro, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3016733629 (openFDA record; or search FDA's registration database)
- FEI number
- 3016733629
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer
- Owner or operator
- Gilero, Inc (FDA owner/operator no. 10053703)
- Registered address
- 158 Credle Street, Pittsboro, NC 27312
- Contract listings
- 13 device listings, 11 product codes, first listed Jan 3, 2017
- 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 |
|---|---|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | Class II | General hospital | Contract manufacturing | May 12, 2023 |
| BYZ | Trap, Sterile Specimen | Class II | General hospital | Contract manufacturing | Jan 3, 2017 |
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | Anesthesiology | Contract manufacturing | May 12, 2023 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract manufacturing | Jan 17, 2025 |
| EXX | Probe, Rectal, Non-Powered | Class I | Gastroenterology and urology | Contract manufacturing | Jul 20, 2023 |
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Jun 29, 2021 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jul 20, 2023 |
| KXG | Applicator, Absorbent Tipped, Sterile | Class I | General hospital | Contract manufacturing | Jan 20, 2021 |
| MLY | Vapocoolant Device | Unclassified | Physical medicine | Contract manufacturing | Mar 22, 2021 |
| PTL | Wire, Guide, Catheter, Exempt | Class II | Cardiovascular | Contract manufacturing | Sep 15, 2020 |
| QOI | Intravenous Catheter Force-Activated Separation Device. | Class II | General hospital | Contract manufacturing | Jun 28, 2022 |