Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615583

FEI Number

3003171455

Entity Name

Dongguan Mars Medical Products Co., Ltd.

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Room 301, 2nd Building, 6# Manfeng Industrial West Road One, Shatian Town, Dongguan City Guangdong 523993, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Mars Medical Products Co., Ltd (Owner Number: 10028732)

Owner / Operator Contact Address

Room 301, 2nd Building, 6# Manfeng Industrial West Road One,, Shatian Town, Dongguan, CN-GD 523993, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K972213

PMA Number

N/A

All Registered Proprietary Names

Omni Original MARS N95 MASK Mars Clinical electronic thermometer,MARS-E-01 IBD MARS

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	2009-03-01
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2026-06-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-06-16
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2019-06-19
PXH	Thermometer Kit	General Hospital	Class 2	880.2910	2021-01-05
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2009-03-01

Official Correspondent

Mei Yun Lin

US Agent Details

Alan Lee Business: AMTAI Medical Equipment, Inc. Email: alanlee@amtai.com Phone: (919) 6990875

Related Public Records

Same Entity

Dongguan Mars Medical Products 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.

Similar Registrations

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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 9615583. Last updated year: 2026. Please use registration number 9615583 when referencing this establishment in official correspondence.