Contract manufacturerKuro Medical (Eden Prairie, MN)MinnesotaGeneral and plastic surgeryGastroenterology and urologyEar, nose and throatNeurologyClass IClass II
Kuro Medical
Contract manufacturer ยท Eden Prairie, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3017496797 (openFDA record; or search FDA's registration database)
- FEI number
- 3017496797
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- One Life Sciences, Inc. (FDA owner/operator no. 10078335)
- Registered address
- 7625 Golden Triangle Dr Ste G, Eden Prairie, MN 55344
- Contract listings
- 4 device listings, 5 product codes, first listed Apr 16, 2025
- 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 |
|---|---|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Apr 16, 2025 |
| KPM | Shunt, Peritoneal | Class II | Gastroenterology and urology | Contract manufacturing | Apr 16, 2025 |
| MIB | Elastomer, Silicone Block | Class II | Ear, nose and throat | Contract manufacturing | Sep 3, 2025 |
| NYV | Gastrointestinal Motility System, Capsule | Class II | Gastroenterology and urology | Contract manufacturing | Jul 1, 2025 |
| OBP | Transcranial Magnetic Stimulator | Class II | Neurology | Contract manufacturing | Mar 31, 2026 |