# Innopex Limited (foreign exporter, Toronto Ontario, CA): 89 new FDA device listings, incl. bag, urine collection, leg, for external use, sterile

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Innopex Limited |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Toronto Ontario, CA |
| New listings | 89 |
| Devices | Bag, Urine Collection, Leg, For External Use, Sterile; Esthesiometer; Mattress, Flotation Therapy, Non-Powered; Catheter, Urological; Adaptor, Hygiene; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Polymer Patient Examination Glove; Syringe, Piston; Catheter, Irrigation; Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Product codes | FAQ, GXB, IKY, KOD, ILS, OPJ, LZA, FMF, GBX, JKA, FRO, KME, NAB, FTY, KGO |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Gastroenterology, Urology, Neurology, General Hospital, Physical Medicine, General, Plastic Surgery, Clinical Chemistry, Pathology, Cardiovascular, Anesthesiology, Obstetrics/Gynecology, Microbiology |
| Brand names | wound dressing; Blood collection tubes; Needle Injection Dispossable; Syringe Piston; surgical cap |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-10-23 |
| FDA registration number | 3001124136 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

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: 2026-11-04T21:52:36.524Z.
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.