Contract manufacturerPOLO CUSTOM PRODUCTS (Monticello, IA)IowaCardiovascularPhysical medicineClass IIIClass II
POLO CUSTOM PRODUCTS
Contract manufacturer ยท Monticello, IA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1927395 (openFDA record; or search FDA's registration database)
- FEI number
- 1927395
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Polo Custom Products (FDA owner/operator no. 9919026)
- Registered address
- 902 NORTH BIRCH RD., Monticello, IA 52310
- Contract listings
- 4 device listings, 4 product codes, first listed Aug 18, 2021
- 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 |
|---|---|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | Class III | Cardiovascular | Contract manufacturing | Jan 10, 2025 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract manufacturing | Dec 4, 2023 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | Physical medicine | Contract manufacturing | Feb 5, 2025 |
| MVK | Wearable Automated External Defibrillator | Class III | Cardiovascular | Contract manufacturing | Aug 18, 2021 |