Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017825461

FEI Number

3017825461

Entity Name

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

City/State/Country

Danyang Jiangsu, CN

Establishment Address

No.1 Baisheng Road Development Zone,, Danyang Jiangsu 212300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (Owner Number: 10084002)

Owner / Operator Contact Address

No.1 Baisheng Road Development Zone,, Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253228

PMA Number

N/A

All Registered Proprietary Names

YE660E PRO MDSBPECON MDSBPADVAN Electronic Blood Pressure Monitor models YE620B,YE620D,YE660E,YE660F,YE680B YE670A PLUS YE660D PLUS YE680B PRO YE660D PRO YUWELL® Electronic Blood Pressure Monitor YE630CR Oxygen Concentrator models 8F-3A,8F-5A Inogen Voxi 5 Portable Oxygen Concentrator Spirit-3 Portable Oxygen Concentrator SP-3 YUWELL Finger Pulse Oximeter models YX105, YX106, YX110, YX310 Electronic Blood Pressure Monitor models YE650A,YE650D,YE670A,YE670D,YE660B YUWELL Infrared Thermometer models YT-1,YT-1A,YT-1B,YT-1C,YT-2,YT-2A,YT-2B,YT-2C Cardinal Health YUWELL® Electronic Blood Pressure Monitor YE650AR

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	2022-01-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-09
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-06-30
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-06-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-02-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-01-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-01-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-09

Official Correspondent

No official correspondent registered.

US Agent Details

Fang(Fawn) Zhang Business: Yuwell MedTech USA LLC Email: fawn.zhang@yuwell.com Phone: (206) 6391311

Related Public Records

Same Entity

Jiangsu Yuyue Medical Equipment & Supply 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-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651

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 3017825461. Last updated year: 2026. Please use registration number 3017825461 when referencing this establishment in official correspondence.