Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028107593

FEI Number

3028107593

Entity Name

HIAN (HONG KONG) CO., LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong., Hong Kong 94085, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Hian (Hong Kong) Co., Limited (Owner Number: 10088625)

Owner / Operator Contact Address

Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong., Hong Kong, HK-NOTA 94085, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251085

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-09-06
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-11-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-09-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-09-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-12-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-09-18
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2023-12-08
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2025-12-17
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2025-08-10
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2023-09-06
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-09-25
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2025-02-07
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-12-18

Official Correspondent

Patric Wilson

US Agent Details

Yange Wang Business: IHEALTH LABS, INC Email: policy@ihealthlabs.com Phone: (408) 6638349

Related Public Records

Same Entity

Hian (Hong Kong) Co., Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028107593. Last updated year: 2026. Please use registration number 3028107593 when referencing this establishment in official correspondence.