Contract manufacturerONTOGEN MANUFACTURING LLC (Lisle, IL)IllinoisCardiovascularGastroenterology and urologyGeneral hospitalNeurologyClass IIClass I
ONTOGEN MANUFACTURING LLC
Contract manufacturer · Lisle, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3038472982 (openFDA record; or search FDA's registration database)
- FEI number
- 3038472982
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Ontogen Manufacturing LLC (FDA owner/operator no. 10093548)
- Registered address
- 815 Ogden Ave, Lisle, IL 60532
- Contract listings
- 5 device listings, 8 product codes, first listed Jun 2, 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 |
|---|---|---|---|---|---|
| DPS | Electrocardiograph | Class II | Cardiovascular | Contract manufacturing | Aug 31, 2026 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class II | Cardiovascular | Contract manufacturing | Aug 31, 2026 |
| DXR | Ballistocardiograph | Class II | Cardiovascular | Contract manufacturing | Aug 31, 2026 |
| EYI | Adaptor, Ureteral Catheter | Class I | Gastroenterology and urology | Contract manufacturing | May 15, 2026 |
| FON | Bag, Drainage, With Adhesive, Ostomy | Class I | Gastroenterology and urology | Contract manufacturing | Dec 19, 2025 |
| FQH | Lavage, Jet | Class II | General hospital | Contract manufacturing | Dec 19, 2025 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract manufacturing | Jun 2, 2025 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Class II | Cardiovascular | Contract manufacturing | Aug 31, 2026 |