Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045076259

FEI Number

3045076259

Entity Name

TIANMEN XUANYUE MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Tianmen Hubei, CN

Establishment Address

No. 150, Jieguan Road, Economic Development Zone, Tianmen Hubei 431700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tianmen Xuanyue Medical Equipment Co., Ltd. (Owner Number: 10095776)

Owner / Operator Contact Address

No. 150, Jieguan Road, Economic Development Zone, Tianmen, CN-HB 431700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WinCare, XY-GD02, XY-NCXY, XY-1004, XY-1005, XY-D1, XY-NCMY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2026-04-27

Official Correspondent

Dan Liu

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Tianmen Xuanyue Medical Equipment Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2032685	HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP.	LOS ANGELES, CA, US
3013257234	MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD	Dongguan Guangdong, CN
3015277818	HANGZHOU WEIZE IMP & EXP CO., LTD	Hangzhou Zhejiang, CN
3042277519	CHANGZHOU SAISHENG MEDICAL TECHNOLOGY CO., LTD	Changzhou Jiangsu, CN
3018975080	SHENZHEN MICRO ELECTRIC INTELLIGENCE CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3045076259. Last updated year: 2026. Please use registration number 3045076259 when referencing this establishment in official correspondence.