Contract manufacturerBIOMERICS (Salt Lake City, UT)UtahCardiovascularGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryNeurologyOphthalmicClass IIClass I
BIOMERICS
Contract manufacturer · Salt Lake City, UT
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3008998256 (openFDA record; or search FDA's registration database)
- FEI number
- 3008998256
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Biomerics (FDA owner/operator no. 10042380)
- Registered address
- 6030 W Harold Gatty Drive, Salt Lake City, UT 84116
- Contract listings
- 20 device listings, 17 product codes, first listed Nov 21, 2012
- 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 |
|---|---|---|---|---|---|
| DQR | Cannula, Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 20, 2020 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Nov 20, 2020 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Nov 20, 2020 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract manufacturing | Nov 20, 2020 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 20, 2020 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract manufacturing | Apr 29, 2024 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract manufacturing | Nov 26, 2019 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Nov 20, 2020 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Aug 27, 2020 |
| GXI | Probe, Radiofrequency Lesion | Class II | Neurology | Contract manufacturing | Nov 21, 2012 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Dec 15, 2020 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Aug 27, 2020 |
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology and urology | Contract manufacturing | Feb 9, 2016 |
| MHC | Needle, Interosseous | Class II | General hospital | Contract manufacturing | Mar 9, 2021 |
| MSD | Catheter, Hemodialysis, Implanted | Class II | Gastroenterology and urology | Contract manufacturing | Apr 6, 2021 |
| OFD | Catheter Introducer Kit | Class II | Cardiovascular | Contract manufacturing | Dec 19, 2022 |
| PDU | Catheter For Crossing Total Occlusions | Class II | Cardiovascular | Contract manufacturing | Dec 27, 2023 |