Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030432749

FEI Number

3030432749

Entity Name

RUGAO SMILING HEALTHCARE TECONOLGY DEVELOPENT CO., LTD

City/State/Country

Rugao Jiangsu, CN

Establishment Address

Group 17, Zouzhuang Village, Xiyuan Town, Rugao, Jiangsu, China, Rugao Jiangsu 226500, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Rugao Smiling Healthcare Teconolgy Developent Co., Ltd (Owner Number: 10090019)

Owner / Operator Contact Address

Group 17, Zouzhuang Village, Xiyuan Town, Rugao, Jiangsu, China, Rugao, CN-JS 226500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DEVICE, TRANSFER, PATIENT, MANUAL GARMENT, PROTECTIVE,FOR INCONTINENCE NON-SURGICAL ISOLATION GOWN GOWN, EXAMINATION COVER, METTRESS(MEDICAL PURPOSE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-02-03
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2024-02-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-02-03
FME	Gown, Examination	General Hospital	Class 1	880.6265	2024-02-03
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-02-03

Official Correspondent

Jianhua Lu

US Agent Details

ZHIGANG ZHANG Email: BONNY008@proton.me Phone: (302) 3985328

Related Public Records

Same Entity

Rugao Smiling Healthcare Teconolgy Developent Co., Ltd

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 3030432749. Last updated year: 2026. Please use registration number 3030432749 when referencing this establishment in official correspondence.