FDA Registration
Active
🇨🇦 Canada
STAR ELITE
Reg #: 3004835896
·
FEI: 3004835896
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- STAR ELITE
- Registration Number
- 3004835896
- FEI Number
- 3004835896
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1175 Place du Frere-Andre
- City
- Montreal Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K082641
Owner / Operator
- Firm Name
- Star Elite Inc.
- Operator Number
- 10081950
- Address
- 1175 Place du Frere-Andre
- City
- Montreal
- State
- Quebec
- Postal Code
- H3B 3X9
- Country
- CA
- Correspondent
- Dimitri Paraskevopoulos
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-06-01 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-06-01 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2024-12-03 |
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2023-01-10 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-06-02 |
Proprietary Names
Pulse Oximeter
Wrist Blood Pressure Monitor
Body Analysis Scale
Infrared Thermometer
Arm Blood Pressure Monitor
Non-Contact Forehead Thermometer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor