FDA Registration
Active
🇹🇼 Taiwan
Thermometer, Model TH8 series
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
- K011059
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 | 2007-11-25 |
Proprietary Names
Thermometer, Model TH8 series
Infrared Ear Thermometer Probe Cover, Model PC7200
Infrared Ear Thermometer Probe Cover, Model PCL A40
Infrared Ear Thermometer Probe Cover, Model PC 840
Infrared Ear Thermometer Probe Cover, Model MDS9701
Thermometer, Model MDS9700
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility