# 15445361 Canada Inc. (foreign exporter, Shawinigan Quebec, CA): 26 new FDA device listings, incl. system, thermal regulating

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | 15445361 Canada Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Shawinigan Quebec, CA |
| New listings | 26 |
| Devices | System, Thermal Regulating; Container, Liquid Medication, Graduated; Lubricant, Patient; Catheter, Retention Type, Balloon; Stethoscope, Manual; Set, Administration, Intravascular; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tubing, Noninvasive; Latex Patient Examination Glove; Cannula, Surgical, General & Plastic Surgery |
| Product codes | DWJ, KYW, KMJ, EZL, LDE, FPA, JKA, GAZ, LYY, GEA, FQM, FYF, DRX, FMF, BYX |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Cardiovascular, General Hospital, Gastroenterology, Urology, Clinical Chemistry, General, Plastic Surgery, Anesthesiology, Neurology |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-10-20 |
| FDA registration number | 3043051314 |
| Registration expires | 2026-12-31 |

## 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.