Contract manufacturerNextern (Maple Grove, MN)MinnesotaCardiovascularGastroenterology and urologyObstetrics and gynecologyEar, nose and throatClass II
Nextern
Contract manufacturer · Maple Grove, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3031976597 (openFDA record; or search FDA's registration database)
- FEI number
- 3031976597
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Nextern Innovation, Inc (FDA owner/operator no. 10037078)
- Registered address
- 10601 Fountains Drive, Maple Grove, MN 55369
- Contract listings
- 6 device listings, 6 product codes, first listed May 10, 2022
- 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 |
|---|---|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | Class II | Cardiovascular | Contract manufacturing | Feb 21, 2025 |
| EXY | Uroflowmeter | Class II | Gastroenterology and urology | Contract manufacturing | Feb 26, 2026 |
| HIR | Perineometer | Class II | Obstetrics and gynecology | Contract manufacturing | Apr 9, 2024 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract manufacturing | Mar 27, 2023 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Class II | Cardiovascular | Contract manufacturing | May 10, 2022 |
| QQH | Powered Insertion System For A Cochlear Implant Electrode Array | Class II | Ear, nose and throat | Contract manufacturing | Dec 2, 2024 |