FDA Registration
Active
🇭🇰 Hong Kong
TRULY INSTRUMENT LIMITED
Reg #: 3003657019
·
FEI: 3003657019
·
Expires 2026
Products
3
Proprietary Names
13
Establishment Types
4
Classifications
3
Registration Details
- Registration Name
- TRULY INSTRUMENT LIMITED
- Registration Number
- 3003657019
- FEI Number
- 3003657019
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2ND FLOOR, 1-3 WING YIP ST.
- City
- KWAI CHUNG
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K014141
Owner / Operator
- Firm Name
- TRULY INSTRUMENT LIMITED
- Operator Number
- 9054344
- Address
- 2ND FLOOR, 1-3 WING YIP ST., --
- City
- KWAI CHUNG
- State
- HK-NOTA
- Postal Code
- --
- Country
- HK
US Agent
- Business Name
- Truly (U.S.A.) Inc.
- Contact Name
- Max Wong
- Address
- 2620 Concord Avenue, Suite 106
- City
- Alhambra
- State
- CA
- ZIP
- 91803
- Country
- US
- [email protected]
- Phone
- 626 2843033
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2008-05-09 |
| Toothbrush, Ionic, Battery-Powered | MMD | Class 1 | Dental | No | 2002-12-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2009-12-03 |
Proprietary Names
Blood Pressure Monitor
Truly
Masters
ReliaMed
SureLife
SAMICO
Andesfit Limited
Truly Power Toothbrush
TRULY
Truly Automatic Blood Pressure Monitor
PressurePlus Automatic Blood Pressure Monitor
Infopia Automatic Blood Pressure Monitor
SmartDiabetes Automatic Blood Pressure Monitor
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device