Contract manufacturerCARESTREAM HEALTH, INC. (Rochester, NY)New YorkGastroenterology and urologyRadiologyClass II
CARESTREAM HEALTH, INC.
Contract manufacturer ยท Rochester, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3015532525 (openFDA record; or search FDA's registration database)
- FEI number
- 3015532525
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Carestream Health, Inc. (FDA owner/operator no. 9097221)
- Registered address
- 882 Linden Ave., Rochester, NY 14625
- Contract listings
- 5 device listings, 5 product codes, first listed Feb 28, 2020
- 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 |
|---|---|---|---|---|---|
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | Class II | Gastroenterology and urology | Contract manufacturing | Feb 28, 2020 |
| FCW | Light Source, Fiberoptic, Routine | Class II | Gastroenterology and urology | Contract manufacturing | Feb 28, 2020 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Feb 28, 2020 |
| IZI | System, X-Ray, Angiographic | Class II | Radiology | Contract manufacturing | Feb 28, 2020 |
| OWN | Confocal Optical Imaging | Class II | Gastroenterology and urology | Contract manufacturing | Feb 28, 2020 |