FDA Registration
Active
🇨🇦 Canada
AMICO DIAGNOSTIC INCORPORATED
Reg #: 3009685433
·
FEI: 3009685433
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- AMICO DIAGNOSTIC INCORPORATED
- Registration Number
- 3009685433
- FEI Number
- 3009685433
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 122 East Beaver Creek Road
- City
- Richmond Hill Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K003313
Owner / Operator
- Firm Name
- Amico Diagnostic Incorporated
- Operator Number
- 10040947
- Address
- 122 East Beaver Creek Road
- City
- Richmond Hill
- State
- Ontario
- Postal Code
- L4B 4V1
- Country
- CA
- Correspondent
- Jack Chang
US Agent
- Business Name
- AJW Technology Consultants, Inc.
- Contact Name
- Jon Ward
- Address
- 11705 Boyette Road, #503
- City
- Riverview
- State
- FL
- ZIP
- 33569
- Country
- US
- [email protected]
- Phone
- 813 6452855 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2015-03-23 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-03-04 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2014-08-28 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2012-06-05 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2012-06-05 |
Proprietary Names
MANUAL STETHOSCOPE - STHETHOSCOPES MULTIPLE & ACCESSORIES
ELECTRONIC THERMOMETER
OPHTHALMOSCOPES MULTIPLE & ACCESSORIES
OPHTHALMOSCOPES - AC-POWERED
BLOOD PRESSURE CUFFS & DEVICES
INFRARED TYMPANIC ELECTRONIC THERMOMETER
OTOSCOPE AC/DC POWERED
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device