FDA Registration
Active
🇨🇦 Canada
TRAFEROX TECHNOLOGIES INC.
Reg #: 3027669473
·
FEI: 3027669473
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- TRAFEROX TECHNOLOGIES INC.
- Registration Number
- 3027669473
- FEI Number
- 3027669473
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3505 Laird Rd, Unit 16
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K243870
Owner / Operator
- Firm Name
- Traferox Technologies Inc.
- Operator Number
- 10093353
- Address
- 3505 Laird Rd, Unit 16
- City
- Mississauga
- State
- Ontario
- Postal Code
- L5L 5Y7
- Country
- CA
- Correspondent
- Nicole Baker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2025-05-05 |
Proprietary Names
X°Port Lung Preservation System; X°Port Lung Preservation Solution
VI°Port Liver Preservation System
LungProtect
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device