FDA Registration
Active
🇨🇦 Canada
TULSA-PRO
Reg #: 3012604011
·
FEI: 3012604011
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PROFOUND MEDICAL INC.
- Registration Number
- 3012604011
- FEI Number
- 3012604011
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2400 Skymark Avenue, Unit 6
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K211858
Owner / Operator
- Firm Name
- Profound Medical Inc.
- Operator Number
- 10061262
- Address
- 2400 Skymark Avenue, Unit 6
- City
- Mississauga
- State
- Ontario
- Postal Code
- L4W 5K5
- Country
- CA
- Correspondent
- Imen Ferchichi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| High Intensity Ultrasound System For Prostate Tissue Ablation | PLP | Class 2 | Gastroenterology, Urology | No | 2022-09-08 |
Proprietary Names
TULSA-PRO
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198