Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000163458

FEI Number

3000163458

Entity Name

HEALTH & HEALTH (GROUP) CO.,LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

BLOCK D, BLOCK H and self-compiled Block 1 office building, #282 Caixin Road ,Lanhe Town ,Nansha District, Guangzhou Guangdong 511480, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HEALTH & HEALTH (GROUP) CO.,LTD (Owner Number: 10052997)

Owner / Operator Contact Address

BLOCK D, BLOCK H and self-compiled Block 1 office building, #282 Caixin Road ,Lanhe Town ,Nansha District, Guangzhou, CN-GD 511480, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water Ionizer Infrared Thermometer Disposable Protective Mask, Disposable medical face Mas Electronic Thermometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2016-10-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-05
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-14
PXH	Thermometer Kit	General Hospital	Class 2	880.2910	2020-03-24

Official Correspondent

Kevin Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HEALTH & HEALTH (GROUP) CO.,LTD

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-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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3004488394	TIGER MEDICAL GROUP	SHANGHAI, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000163458. Last updated year: 2026. Please use registration number 3000163458 when referencing this establishment in official correspondence.