FDA Registration
Active
🇻🇳 Vietnam
ONFU electronics Co., LTD.
Reg #: 3016867013
·
FEI: 3016867013
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- ONFU electronics Co., LTD.
- Registration Number
- 3016867013
- FEI Number
- 3016867013
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Street No.3, Song May Industrial Zone, Binh Minh Commune,
- City
- Trang Bom Dong Nai
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K033820
Owner / Operator
- Firm Name
- MICROLIFE CORP.
- Operator Number
- 8020605
- Address
- 9F, 431, RuiGuang Road, NeiHu
- City
- TAIPEI
- State
- TW-TPE
- Postal Code
- 11492
- Country
- TW
US Agent
- Business Name
- mdi Consultants Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd, Suite 200
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2008-09-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-10-29 |
| Device, Fertility Diagnostic, Proceptive | LHD | Class U | Unknown | No | 2008-01-28 |
Proprietary Names
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)