FDA Registration
Active
🇹🇭 Thailand
Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A,VNT275US
Reg #: 3038280948
·
FEI: 3038280948
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDWELL CO.,LTD.
- Registration Number
- 3038280948
- FEI Number
- 3038280948
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 176/1 Moo 7 Soi 7, Gateway City Rd.,Huasomrong, Plaengyao, Chachoengsao 24190
- City
- Gateway Chachoengsao
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K171888
Owner / Operator
- Firm Name
- Medwell CO.,LTD.
- Operator Number
- 10093395
- Address
- 176/1 Moo 7 Soi 7, Gateway City Rd.,Huasomrong, Plaengyao, Chachoengsao 24190
- City
- Gateway
- State
- Chachoengsao
- Postal Code
- 24190
- Country
- TH
- Correspondent
- Tom Chen
US Agent
- Business Name
- managing menber
- Contact Name
- GUO XIAO
- Address
- 73 Rockview
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 949 4914194
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-05-12 |
Proprietary Names
Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A,VNT275US
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)