Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013561145

FEI Number

3013561145

Entity Name

SHENZHEN COMBEI TECHNOLOGY CO.,LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No.105, Huanguan South Road, Dahe Community, Guanhu Street, Longhua District, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENZHEN COMBEI TECHNOLOGY CO.,LTD (Owner Number: 10054917)

Owner / Operator Contact Address

No.105, Huanguan South Road, Dahe Community, Guanhu Street, Longhua District, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Insect Bite Relief, IBH-001 Insect Bite Healer, Model IH-W03 Arm Type Blood Pressure Monitor, model: BP136A, BP126A, BP122A, BP118A, BP116A, BP108A, BP106A HOMIEE, Blood pressure monitor, model: BP1003 CHOICEMMED, Blood pressure monitor, model: CBP1K2 Dynarex, Blood pressure monitor, model: 7096 Dr Trust, Blood pressure monitor, model: BP116A CHOICEMMED, Blood pressure monitor, model: CBP1K1 CHOICEMMED, Blood pressure monitor, model: CBP1K3 HOMIEE, Blood pressure monitor, model: BP1001 Arm Type Blood Pressure Monitor, model: BPT801, BPCB0A-3H, BPCB0A-3A, BPCB0A-2H, BPCB0A-2A, BP880A, BP866A, BP820A Arm Type Blood Pressure Monitor, model: BP810A, BP800A, BP660A, BP200A, BP168A, BP163A, BP156A-A, BP156A Arm Type Blood Pressure Monitor, model: BP105A, BP103A, BP102A, BP101A, BP100A Medisana, Blood pressure monitor, Model: BU 600, BU 600B Wrist Style, Blood pressure monitor, model: BP800W BP603W BP880W BP885W BPCBOA-2F BP850W BP300W HHYLOGY, Blood pressure monitor, model: MD-H21 CHOICEMMED, Blood pressure monitor, model: CBP2K2 CHOICEMMED, Blood pressure monitor, model: CBP2K1 HOMIEE, Blood pressure monitor, model: BP2001 Wrist Style, Blood pressure monitor, model: BP810W BP602W BP608W BP606W BP660W BP830W BP866W CHOICEMMED, Blood pressure monitor, model: CBP2K3 Dynarex, Blood pressure monitor, model: 7095 Combei, ARM Blood Pressure Monitor, model: BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A HOMIEE, Blood pressure monitor, model: BP1001, BP1002 Combei, WristBlood Pressure Monitor, model: BP885W, BP606W, BP800W, BP603W, BP880W, BPCB0A-2F, BP850W, BP300W Combei, WristBlood Pressure Monitor, model: BP810W, BP602W, BP608W, BP606W, BP830W, BP866W Combei, ARM Blood Pressure Monitor, model: BP100A, BP200A, BPCB0A-3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A Infrared Forehead Thermometer, Model: FR200, NC8, NC200, NC100, NC600, NC300 Dual mode Infrared thermometer, Model: IFM100 Infrared ear thermometer, Model: IR100, IR200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-10-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-11-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-02-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-05-12
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-02

Official Correspondent

Kevin Fong

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

SHENZHEN COMBEI TECHNOLOGY 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24

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.

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013561145. Last updated year: 2026. Please use registration number 3013561145 when referencing this establishment in official correspondence.