Contract manufacturerPOLYZEN, LLC (Apex, NC)North CarolinaCardiovascularClass II
POLYZEN, LLC
Contract manufacturer ยท Apex, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1064859 (openFDA record; or search FDA's registration database)
- FEI number
- 3002897588
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- POLYZEN, INC. (FDA owner/operator no. 9034880)
- Registered address
- 1041 Classic Rd, Apex, NC 27539
- Contract listings
- 1 device listings, 1 product codes, first listed Jun 5, 2014
- 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 |
|---|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Jun 5, 2014 |