Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016710298

FEI Number

3016710298

Entity Name

SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 9 Jinfeng Road, Suzhou Science & Technology Town, Suzhou Jiangsu 215163, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD (Owner Number: 10091669)

Owner / Operator Contact Address

No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou Jiangsu, CN 215163, Suzhou, CN-JS 215163, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203347

PMA Number

N/A

All Registered Proprietary Names

YUWELL Standard conical connector Yuwell Sleep Apnea Breathing Therapy Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2024-10-23
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2025-09-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-10-22

Official Correspondent

Yiliang Zhang

US Agent Details

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

Related Public Records

Same Entity

SUZHOU YUYUE 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
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Similar Registrations

Registration Number	Establishment Name	Location
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3014208300	HITEC MEDICAL CO., LTD	Shanghai, CN
3016458361	SHAOXING REBORN MEDICAL DEVICES CO.,LTD	Shaoxing Zhejiang, CN
3031369651	HSINER CO., LTD.	Taichung City, TW
3004134948	ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.	Huzhou City Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016710298. Last updated year: 2026. Please use registration number 3016710298 when referencing this establishment in official correspondence.