FDA Registration
Active
🇨🇳 China
ONBO ELECTRONIC (SHENZHEN) CO. LTD.
Reg #: 9680225
·
FEI: 3003010579
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
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Registration Details
- Registration Name
- ONBO ELECTRONIC (SHENZHEN) CO. LTD.
- Registration Number
- 9680225
- FEI Number
- 3003010579
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.138, Huasheng Road, Langkou Community, Dalang Street, Longhua District
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211288
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 P. 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 |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-10-29 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 1983-07-21 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2012-01-31 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2007-12-05 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2007-12-05 |
| Device, Fertility Diagnostic, Proceptive | LHD | Class U | Unknown | No | 2008-01-28 |
Proprietary Names
PERSONAL RHYTHM CLOCK
LIQUID CRYSTAL RHYTHM THERMOMETER
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)