FDA Registration
Active
🇨🇳 China
ADC CLIA 800,ADC CLIA 600,ADC CLIA 500,ADC CLIA 400,ADC CLIA 300,ADC CLIA 200
Reg #: 3010031137
·
FEI: 3010031137
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Yantai Addcare Bio-Tech Co., Ltd.
- Registration Number
- 3010031137
- FEI Number
- 3010031137
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.10, Nanjing Street, Development Zone
- City
- Yantai Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Yantai Addcare Bio-Tech Co., Ltd.
- Operator Number
- 10054662
- Address
- No.10, Nanjing Street, Development Zone
- City
- Yantai
- State
- Shandong
- Postal Code
- 265501
- Country
- CN
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2017-04-12 |
Proprietary Names
ADC CLIA 800,ADC CLIA 600,ADC CLIA 500,ADC CLIA 400,ADC CLIA 300,ADC CLIA 200
ELISA Reader DM 801, DM 801B
Fully Automated CLIA workstation iTube 3000, iTube 5000
Chemiluminescence Reader JUDE 96
Fully Automated Biochemistry Analyzer BC-400, BC-600, BC-2000
Fully Automated CLIA and ELISA Workstation ICE 800, ICE 400
Fully Automated CLIA Workstation iTube 1000
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device