FDA Registration
Active
🇭🇰 Hong Kong
HIAN (HONG KONG) CO., LIMITED
Reg #: 3028107593
·
FEI: 3028107593
·
Expires 2026
Products
11
Proprietary Names
19
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- HIAN (HONG KONG) CO., LIMITED
- Registration Number
- 3028107593
- FEI Number
- 3028107593
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong.
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K200531
Owner / Operator
- Firm Name
- Hian (Hong Kong) Co., Limited
- Operator Number
- 10088625
- Address
- Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong.
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- 94085
- Country
- HK
- Correspondent
- Patric Wilson
US Agent
- Business Name
- IHEALTH LABS, INC
- Contact Name
- Yange Wang
- Address
- 880 W MAUDE AVE,SUNNYVALE , CALIFORNIA , 94085 , UNITED STATES
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
- [email protected]
- Phone
- 408 6638349
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-09-06 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-12-09 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2023-12-08 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2025-12-17 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2025-08-10 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2023-09-06 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2023-09-25 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2025-02-07 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-12-18 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2024-05-10 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-01-15 |
Proprietary Names
iHealth (model: PT3)
iHealth (model: PT9L)
iHealth PT9
iHealth (model: PT2L)
iHealth (model: PT5)
iHealth Ease Blood Pressure Monitor (Model: BP3L)
iHealth (model: PT3SBT)
iHealth (model: PO3)
iHealth COVID-19 Antigen Rapid Test (model:ICO-3000)
iHealth Nexus (Model: HS2S)
iHealth COVID-19 Antigen Rapid Test Pro (model: ICO-3000P)
iHealth COVID-19 Antigen Rapid Test (model: ICO-3000)
iHealth Nasal Swab
illealth Fresh Electric Nasal washSystem (model: ANC1)
iHealth Flu A&B/COVID-19/RSV Rapid Test (model: ICR-3000)
iHealth Flu A&B/COVID-19/RSV Rapid Test Pro Control Kit
iHealth COVID-19/Flu A&B Rapid Test
iHealth Early Pregnancy Test (model: IHC-3000)
iHealth (KN-550BT)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device