FDA Registration
Active
🇹🇼 Taiwan
Multi-function Infrared Thermometer, Model TH50Z, TH50ZK, TH500K
Reg #: 9710548
·
FEI: 3003515005
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RADIANT INNOVATION INC.
- Registration Number
- 9710548
- FEI Number
- 3003515005
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1F, NO.3, INDUSTRIAL E. 9TH RD, SCIENCE-BASED INDUSTRIAL PARK
- City
- HSINCHU
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K162083
Owner / Operator
- Firm Name
- RADIANT INNOVATION, INC.
- Operator Number
- 9045429
- Address
- 1F,NO. 3,INDUSTRIAL E. 9TH RD, SCIENCE-BASED INDUSTRIAL PARK
- City
- HSINCHU
- State
- TW-NOTA
- Postal Code
- 300
- Country
- TW
US Agent
- Business Name
- MDI CONSULTANTS, INC.
- Contact Name
- ALAN Schwartz
- Address
- 55 NORTHERN BLVD., SUITE 200
- City
- GREAT NECK
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-01-10 |
Proprietary Names
Multi-function Infrared Thermometer, Model TH50Z, TH50ZK, TH500K
RII Multi-function Infrared Thermometer, Model TH52Z
Multi-function Infrared Thermometer, Model TH520. TH520K
Multi-function Infrared Thermometer, Model THi0K,THi0KZ
Multi Function Infrared Thermometer, Model UT-801-FSA
Multi-function Infrared Thermometer, Model TH005K, TH007K
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility