FDA Registration
Active
🇨🇦 Canada
ANDA Medical
Reg #: 3015223550
·
FEI: 3015223550
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ANDA Medical
- Registration Number
- 3015223550
- FEI Number
- 3015223550
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 330 Marwood Dr., Unit 4
- City
- Oshawa Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K253185
Owner / Operator
- Firm Name
- ANDA Medical
- Operator Number
- 10083854
- Address
- 330 Marwood Drive, Unit 3
- City
- Oshawa
- State
- Ontario
- Postal Code
- L1H8B4
- Country
- CA
- Correspondent
- Taylor Bailie
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2026-04-16 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2026-04-16 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2025-08-13 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-12-05 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2025-11-19 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-11-19 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-11-19 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2021-12-23 |
Proprietary Names
CARESTREAM DRX REVOLUTION MOBILE XRAY SYSTEM
GE Lightspeed VCT CT
GE 1.5T Twinspeed MRI
GE OPTIMA XR 220AMX PORTABLE XRAY MACHINE
Philips Veradius C-Arm
Siemens Arcadis Avantic C-Arm
OEC 9800 Plus C-Arm
Gastroscope
Establishment Types
Export Device to the United States But Perform No Other Operation on Device