Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015007456

FEI Number

3015007456

Entity Name

SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA., SHENZHEN Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen IMDK Medical Technology Co., Ltd. (Owner Number: 10058601)

Owner / Operator Contact Address

904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA., SHENZHEN, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253133

PMA Number

N/A

All Registered Proprietary Names

Arm Blood Pressure Monitor (model: BPM-A7L) Arm Blood Pressure Monitor (model: BPM-A7VL) Arm Blood Pressure Monitor (model: BPM-A7) Arm Blood Pressure Monitor (model: BPM-A7V) Pulse Oximeter-C101A2 C101H1 C101B1 C101B2 C101A3 Pulse Oximeter (Model C101a2, C101b1, C101a3) Pulse Oximeter C101H1 Ultrasonic Doppler (Model YM-2T8) Wrist Blood Pressure Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-12-02
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-12-02
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2020-11-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-10-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-13
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2018-10-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-02-26

Official Correspondent

XIA YUAN

US Agent Details

Hui Hong Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Shenzhen IMDK Medical 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
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
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

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-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015007456. Last updated year: 2026. Please use registration number 3015007456 when referencing this establishment in official correspondence.