Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017133271

FEI Number

3017133271

Entity Name

ROSTI INTEGRATED MANUFACTURING SOLUTIONS (SUZHOU) CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.1 HuaZheng Street, Suzhou Industrial Park, Suzhou Jiangsu 215028, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. (Owner Number: 10084775)

Owner / Operator Contact Address

No.1 HuaZheng Street, Suzhou Industrial Park, Suzhou, CN-JS 215028, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nu Skin RenuSpa iO TENA SMART CARE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2023-11-23
KPN	Alarm, Conditioned Response Enuresis	Gastroenterology, Urology	Class 2	876.2040	2022-03-30

Official Correspondent

Dong Qin

US Agent Details

James Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Rosti Integrated Manufacturing Solutions (Suzhou) 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
K780660	Nite Train-R Enterprises, Inc.	NITE TRAIN'R	1978-07-28
K871787	Dilorenzo Engineering Co.	ENURESIS ALARM	1987-08-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017133271. Last updated year: 2026. Please use registration number 3017133271 when referencing this establishment in official correspondence.