FDA Registration
Active
🇨🇳 China
Infrared Thermometer: DT-8836T, DT-8836P
Reg #: 3012295567
·
FEI: 3012295567
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Calibeur Industries Co., Ltd.
- Registration Number
- 3012295567
- FEI Number
- 3012295567
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 11 Bldg., Shiguan Industrial Park, Gongming, Guangming New District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191251
Owner / Operator
- Firm Name
- Shenzhen Calibeur Industries Co., Ltd.
- Operator Number
- 10061521
- Address
- No. 11 Bldg., Shiguan Industrial Park, Gongming, Guangming New District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
US Agent
- Business Name
- Dynasty Medical Consulting Inc.
- Contact Name
- Linda Chen
- Address
- 302 Round Lake Dr
- City
- Rosenberg
- State
- TX
- ZIP
- 77469
- Country
- US
- [email protected]
- Phone
- 832 3809688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-10-24 |
Proprietary Names
Infrared Thermometer: DT-8836T, DT-8836P
Infrared Thermometer: DT-8836D, DT-8836W, DT-8836K, DT-8836C, DT-8836B, DT-8836J, DT-8836M, DT-8836Y, DT-8836S, DT-8836L
Establishment Types
Manufacture Medical Device