FDA Registration
Active
🇨🇳 China
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
Reg #: 3032147516
·
FEI: 3032147516
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ETERBIO, INC.
- Registration Number
- 3032147516
- FEI Number
- 3032147516
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China
- City
- Zhuhai Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243064
Owner / Operator
- Firm Name
- Eterbio, Inc.
- Operator Number
- 10091094
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China
- City
- zhuhai
- State
- Guangdong
- Postal Code
- 519000
- Country
- CN
- Correspondent
- XIAOXIN LIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2025-06-17 |
Proprietary Names
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
ETERBIO Fentanyl/Norfentanyl Home Test
Establishment Types
Manufacture Medical Device