Suzhou Medical Appliance Factory

FDA Device Registration & Listing · Suzhou New District, Suzhou Jiangsu, CN · Registration 8043894

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8043894
FEI Number
3003999642
Entity Name
Suzhou Medical Appliance Factory
City/State/Country
Suzhou New District, Suzhou Jiangsu, CN
Establishment Address
No.18, Huatuo Road, SSTT, Suzhou New District, Suzhou Jiangsu 215163, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
SUZHOU MEDICAL APPLIANCE FACTORY (Owner Number: 10094443)
Owner / Operator Contact Address
No.18, Huatuo Road, SSTT, Suzhou New District, Suzhou, CN-JS 215163, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stick-on Moxa, Hwato Moxa, Hwato Smokeless Moxa HWATO TDP HEAT LAMP Hua-Xia Needles HWATO, HUAXIA & TONY ACUPUNCTURE NEEDLES Dry Needles Press Needles Hwa-To Needles

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2025-11-30
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2025-11-30
MQX Needle, Acupuncture, Single Use General Hospital Class 2 880.5580 2025-11-30

Official Correspondent

Aimin Xu

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 MEDICAL APPLIANCE FACTORY
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043894. Last updated year: 2026. Please use registration number 8043894 when referencing this establishment in official correspondence.
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