FDA Registration
Active
🇹🇼 Taiwan
Thermometer, electronic, clinical
Reg #: 9710548
·
FEI: 3003515005
·
Expires 2025
Products
1
Proprietary Names
7
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
- K111637
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 | 2011-12-22 |
Proprietary Names
Thermometer, electronic, clinical
THP79JU
Infrared Ear Thermometer, Model THP59JB
Infrared Ear Thermometer, Model THP59JU
Infrared Ear Thermometer, Model THP79JB
Infrared Ear Thermometer, Model THP89JB
Infrared Ear Thermometer, Model THP59J
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility