FDA Registration
Active
🇨🇦 Canada
BIOS Diagnostics Temp Scanner Non Contact Forehead 285DI
Reg #: 3006537699
·
FEI: 3006537699
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THERMOR LTD.
- Registration Number
- 3006537699
- FEI Number
- 3006537699
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 16975 Leslie Street
- City
- Newmarket Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K200802
Owner / Operator
- Firm Name
- Thermor Ltd.
- Operator Number
- 10037045
- Address
- 16975 Leslie Street
- City
- Newmarket
- State
- Ontario
- Postal Code
- L3Y 9A1
- Country
- CA
- Correspondent
- Iona Wenzel
US Agent
- Business Name
- Global Test Supply
- Contact Name
- Kelly Medina
- Address
- 312 Raleigh St. Unit 9
- City
- Wilmington
- State
- NC
- ZIP
- 28412
- Country
- US
- [email protected]
- Phone
- 910 4422164 ext. 5101
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-05-11 |
Proprietary Names
BIOS Diagnostics Temp Scanner Non Contact Forehead 285DI
BIOS Diagnostics Non Contact Forehead Thermometer 275DI
Establishment Types
Export Device to the United States But Perform No Other Operation on Device