Contract manufacturerLake Region Medical (Chaska, MN)MinnesotaCardiovascularGeneral and plastic surgeryNeurologyOphthalmicGastroenterology and urologyOrthopedicClass IIClass IClass IIIHDE
Lake Region Medical
Contract manufacturer · Chaska, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2126666 (openFDA record; or search FDA's registration database)
- FEI number
- 2126666
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- Lake Region Medical (FDA owner/operator no. 2126666)
- Registered address
- 340 Lake Hazeltine Dr, Chaska, MN 55318
- Contract listings
- 22 device listings, 17 product codes, first listed Jan 24, 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 |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract manufacturing | Mar 20, 2024 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract manufacturing | Jan 30, 2013 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract manufacturing | Nov 4, 2013 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Class II | Cardiovascular | Contract manufacturing | Dec 7, 2016 |
| DXF | Catheter, Septostomy | Class II | Cardiovascular | Contract manufacturing | Jan 30, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| HCG | Device, Neurovascular Embolization | Class II | Neurology | Contract manufacturing | Jun 5, 2014 |
| HQC | Unit, Phacofragmentation | Class II | Ophthalmic | Contract manufacturing | Mar 2, 2015 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Mar 2, 2015 |
| KNQ | Dilator, Esophageal | Class II | Gastroenterology and urology | Contract manufacturing | Jan 30, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Aug 10, 2015 |
| MCX | Catheter, Coronary, Atherectomy | Class III | Cardiovascular | Contract manufacturing | Nov 21, 2023 |
| MLZ | Vitrectomy, Instrument Cutter | Class II | Ophthalmic | Contract manufacturing | Mar 2, 2015 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Aug 10, 2015 |
| NJE | Intracranial Neurovascular Stent | HDE | Neurology | Contract manufacturing | Mar 20, 2014 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Class II | Cardiovascular | Contract manufacturing | Jan 24, 2013 |
| PDU | Catheter For Crossing Total Occlusions | Class II | Cardiovascular | Contract manufacturing | Jan 30, 2013 |