Contract manufacturerGENESEE BIOMEDICAL, INC. (Denver, CO)ColoradoCardiovascularClass II
GENESEE BIOMEDICAL, INC.
Contract manufacturer ยท Denver, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1723241 (openFDA record; or search FDA's registration database)
- FEI number
- 1000517719
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- GENESEE BIOMEDICAL, INC. (FDA owner/operator no. 9012312)
- Registered address
- 700 W Mississippi Ave Unit D5, Denver, CO 80223
- Contract listings
- 2 device listings, 2 product codes, first listed Dec 21, 2007
- 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 |
|---|---|---|---|---|---|
| DWC | Controller, Temperature, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Dec 21, 2007 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Jun 27, 2017 |