Contract manufacturerELITE CUSTOM SOLUTIONS (Rochester, MN)MinnesotaGastroenterology and urologyClass II
ELITE CUSTOM SOLUTIONS
Contract manufacturer ยท Rochester, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004743815 (openFDA record; or search FDA's registration database)
- FEI number
- 3004743815
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Elite Custom Solutions (FDA owner/operator no. 10089531)
- Registered address
- 2450 Marion rd Se, Rochester, MN 55904
- Contract listings
- 1 device listings, 1 product codes, first listed Dec 14, 2023
- 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 |
|---|---|---|---|---|---|
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | Class II | Gastroenterology and urology | Contract manufacturing | Dec 14, 2023 |