FDA Registration
Active
🇭🇰 Hong Kong
Blood Glucose Meter
Reg #: 3024379416
·
FEI: 3024379416
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD
- Registration Number
- 3024379416
- FEI Number
- 3024379416
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- FLAT/RM 04-05 16/F THE BROADWAY NO 54-62 LOCKHART ROAD WANCHAI
- City
- Hongkong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K191657
Owner / Operator
- Firm Name
- EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD
- Operator Number
- 10086256
- Address
- FLAT/RM 04-05 16/F THE BROADWAY NO 54-62 LOCKHART ROAD WANCHAI
- City
- Hongkong
- State
- HK-NOTA
- Postal Code
- 000000
- Country
- HK
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-07-03 |
Proprietary Names
Blood Glucose Meter
G-427B, MG1
Establishment Types
Export Device to the United States But Perform No Other Operation on Device