# Ontogen Manufacturing LLC (contract manufacturer, Lisle, IL): 5 new FDA device listings, incl. adaptor, ureteral catheter

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Ontogen Manufacturing LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Lisle, IL, US |
| New listings | 5 |
| Devices | Adaptor, Ureteral Catheter; Plethysmograph, Photoelectric, Pneumatic Or Hydraulic; Ballistocardiograph; Electrocardiograph; Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Product codes | EYI, JOM, DXR, DPS, DRG |
| Device classes | Class I, Class II |
| Medical specialties | Gastroenterology, Urology, Cardiovascular |
| First new listing | 2026-05-15 |
| Latest new listing | 2026-08-31 |
| FDA registration number | 3038472982 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.