FDA Registration
Active
🇨🇦 Canada
VENTRIPOINT DIAGNOSTICS LTD.
Reg #: 3007194257
·
FEI: 3007194257
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- VENTRIPOINT DIAGNOSTICS LTD.
- Registration Number
- 3007194257
- FEI Number
- 3007194257
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18 Hook Avenue, Unit 101
- City
- Toronto Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K191493
Owner / Operator
- Firm Name
- Ventripoint Diagnostics Ltd.
- Operator Number
- 10046630
- Address
- 18 Hook Avenue, Unit 101
- City
- Toronto
- State
- Ontario
- Postal Code
- M6P1T4
- Country
- CA
- Correspondent
- Aaron Zhang
US Agent
- Business Name
- PAXMED INTERNATIONAL, LLC
- Contact Name
- Floyd Larson
- Address
- 1925 Palomar Oaks Way Ste 210
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
- [email protected]
- Phone
- 858 7921235
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2020-01-09 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-01-09 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-01-09 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-01-09 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-03-18 |
Proprietary Names
Ventripoint Medical System Plus (Vms+) 3
Ventripoint Medical System Plus (VMS+) 4
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device