Contract manufacturerKLUGE DESIGN INC. (Rogers, MN)MinnesotaCardiovascularGeneral and plastic surgeryGastroenterology and urologyRadiologyClass IIClass I
KLUGE DESIGN INC.
Contract manufacturer · Rogers, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003661577 (openFDA record; or search FDA's registration database)
- FEI number
- 3003661577
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Kluge Design LLC (FDA owner/operator no. 10030771)
- Registered address
- 14150 Northdale Blvd, Rogers, MN 55374
- Contract listings
- 10 device listings, 10 product codes, first listed Dec 26, 2012
- 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 |
|---|---|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Dec 26, 2012 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Dec 17, 2013 |
| GDX | Scalpel, One-Piece | Class I | General and plastic surgery | Contract manufacturing | Dec 26, 2012 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology and urology | Contract manufacturing | Nov 20, 2025 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Class II | Cardiovascular | Contract manufacturing | Mar 10, 2014 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | Class I | Cardiovascular | Contract manufacturing | Sep 3, 2024 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Class II | Radiology | Contract manufacturing | Nov 30, 2022 |
| MLW | Warmer, Peritoneal Dialysate | Class II | Gastroenterology and urology | Contract manufacturing | Nov 4, 2024 |
| MPB | Catheter, Hemodialysis, Non-Implanted | Class II | Gastroenterology and urology | Contract manufacturing | Nov 20, 2025 |
| NQJ | Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use | Class II | Gastroenterology and urology | Contract manufacturing | Nov 20, 2025 |