FDA Registration
Active
🇨🇦 Canada
15445361 CANADA INC.
Reg #: 3043051314
·
FEI: 3043051314
·
Expires 2026
Products
22
Proprietary Names
0
Establishment Types
1
Classifications
22
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Registration Details
- Registration Name
- 15445361 CANADA INC.
- Registration Number
- 3043051314
- FEI Number
- 3043051314
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 460 203e Rue
- City
- Shawinigan Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K001924
Owner / Operator
- Firm Name
- 15445361 Canada Inc.
- Operator Number
- 10094832
- Address
- 460 203e Rue
- City
- Shawinigan
- State
- Quebec
- Postal Code
- G9T 6R5
- Country
- CA
US Agent
- Business Name
- Willow Glen Consultancy LLC
- Contact Name
- Wen Wang
- Address
- 8880 Rio San Diego Dr Ste 800
- City
- San Diego
- State
- CA
- ZIP
- 92108
- Country
- US
- [email protected]
- Phone
- 619 8690249
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2026-03-25 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-06-15 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2026-06-15 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-03-14 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2026-03-14 |
| Esthesiometer | GXB | Class 1 | Neurology | No | 2026-06-16 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2026-03-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-01-27 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2026-03-11 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2026-03-14 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2026-03-25 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2026-06-16 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-12-26 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2026-03-08 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2026-05-08 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2026-03-08 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2026-06-19 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2026-03-08 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2026-06-19 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2026-03-14 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-01-20 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device