15445361 Canada Inc. (foreign exporter, Shawinigan Quebec, CA): 26 new FDA device listings, incl. system, thermal regulating
15445361 Canada Inc. (Shawinigan Quebec, California): 26 new FDA device listings, incl. system, thermal regulating. Its amount of 26 is top-decile (98th percentile of 2,709 records). Dated 16 days ago, it is in the active follow-up window. Score 65/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 26 · 98th percentile of 2,709 DeviceEstablishmentPulse records · 13.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 309 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 98th of 2,709 (median 2, 13.0x median) |
| Peer records CSV (310 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-20
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CA first): Icu Medical, Inc. (specification developer, San Clemente, CA · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Citest Diagnostics Inc. (repackager or relabeler, VANCOUVER · Cgbio USA, Inc. (repackager or relabeler, Irvine, CA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: 15445361 Canada Inc. and 310 California peers
- California DeviceEstablishmentPulse records like this one: 310
- 15445361 Canada Inc.'s amount: 98th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $62,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for 15445361 Canada Inc. in Shawinigan Quebec, California?
15445361 Canada Inc. (Shawinigan Quebec, CA), a foreign exporter, added 26 FDA device listings between 2026-05-08 and 2026-10-20.
How does 15445361 Canada Inc. compare to other California DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 26 is 13.0x the median of 2 across 2,709 records. It is 16 days old, still within a typical 45-day follow-up window.
15445361 Canada Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| 15445361 Canada Inc. | Shawinigan Quebec, CA | 26 | 98th | 2026-10-20 |
| Kash Sales Inc. | Richmond Hill Ontario, CA | 8 | 90th | 2026-10-16 |
| Imperial Optical, Inc | Town Of Mount Royal, Quebec, CA | 3 | 77th | 2026-10-22 |
| Innopex Limited | Toronto Ontario, CA | 89 | 99th | 2026-10-23 |
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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.