Contract manufacturerNORTECH SYSTEMS, INC. (Milaca, MN)MinnesotaAnesthesiologyCardiovascularGeneral hospitalGeneral and plastic surgeryNeurologyPhysical medicineRadiologyGastroenterology and urologyObstetrics and gynecologyClass IIClass IClass III
NORTECH SYSTEMS, INC.
Contract manufacturer ยท Milaca, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2183613 (openFDA record; or search FDA's registration database)
- FEI number
- 2183613
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Nortech Systems, Inc. (FDA owner/operator no. 10032390)
- Registered address
- 925 SIXTH AVENUE NE, Milaca, MN 56353
- Contract listings
- 23 device listings, 22 product codes, first listed Jan 9, 2013
- 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 |
|---|---|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | Class II | Anesthesiology | Contract manufacturing | Aug 16, 2018 |
| BXN | Stimulator, Nerve, Battery-Powered | Class II | Anesthesiology | Contract manufacturing | Aug 11, 2016 |
| BZQ | Monitor, Breathing Frequency | Class II | Anesthesiology | Contract manufacturing | Sep 3, 2024 |
| DQA | Oximeter | Class II | Cardiovascular | Contract manufacturing | Sep 3, 2024 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class II | Cardiovascular | Contract manufacturing | Sep 3, 2024 |
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | Contract manufacturing | May 14, 2013 |
| FQH | Lavage, Jet | Class II | General hospital | Contract manufacturing | Dec 13, 2022 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Mar 16, 2016 |
| GXD | Generator, Lesion, Radiofrequency | Class II | Neurology | Contract manufacturing | Feb 28, 2020 |
| IKN | Electromyograph, Diagnostic | Class II | Physical medicine | Contract manufacturing | Feb 5, 2014 |
| IQI | Orthosis, Limb Brace | Class I | Physical medicine | Contract manufacturing | Feb 25, 2021 |
| IZD | Probe, Uptake, Nuclear | Class I | Radiology | Contract manufacturing | Sep 18, 2017 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | Class II | Gastroenterology and urology | Contract manufacturing | Feb 5, 2014 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class II | Gastroenterology and urology | Contract manufacturing | May 29, 2018 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Jan 9, 2013 |
| KOI | Stimulator, Nerve, Peripheral, Electric | Class II | Anesthesiology | Contract manufacturing | Mar 1, 2017 |
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | Class III | Anesthesiology | Contract manufacturing | Sep 20, 2024 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | Cardiovascular | Contract manufacturing | Sep 3, 2024 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Sep 3, 2024 |
| NAM | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | Class II | Gastroenterology and urology | Contract manufacturing | Jul 8, 2013 |
| NRB | Wound Cleaner, Ultrasound | Class II | General and plastic surgery | Contract manufacturing | Sep 3, 2024 |
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | Class II | Obstetrics and gynecology | Contract manufacturing | Nov 6, 2014 |