FDA Registration
Active
🇺🇸 United States
Nextern
Reg #: 3031976597
·
FEI: 3031976597
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- Nextern
- Registration Number
- 3031976597
- FEI Number
- 3031976597
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10601 Fountains Drive
- City
- Maple Grove
- State
- MN
- ZIP
- 55369
- Country
- US
Owner / Operator
- Firm Name
- Nextern Innovation, Inc
- Operator Number
- 10037078
- Address
- 10601 Fountains Drive
- City
- Maple Grove
- State
- MN
- Postal Code
- 55369
- Country
- US
- Correspondent
- Caroline Byrd
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2026-02-26 |
| Powered Insertion System For A Cochlear Implant Electrode Array | QQH | Class 2 | Ear, Nose, Throat | No | 2024-12-02 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2024-04-09 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2022-05-10 |
| Pulse-Generator, Pacemaker, External | DTE | Class 2 | Cardiovascular | No | 2025-02-21 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2023-03-27 |
Proprietary Names
CarePath
IotaSOFT Insertion System
Pelvital Flyte MTI-1.5
Prodigy Thrombectomy System
Solo Pace Control
Symphony Catheter and Dilator
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)