Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015007646

FEI Number

3015007646

Entity Name

Huzhou Sinuo Home Textile Co. LTD

City/State/Country

Huzhou City Zhejiang, CN

Establishment Address

Building C2 China Zhili Children's Clothing Industrial Park Demonstration Park, Zhili Town, Wuxing District, Huzhou City Zhejiang 313008, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Huzhou Sinuo Home Textile Co. (Owner Number: 10058641)

Owner / Operator Contact Address

Building C2, Children's Clothing Demonstration Industrial Park, Zhili Town, Wuxing District, Huzhou City, CN-ZJ 313000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skin Pressure Protector

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	2018-10-17
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-10-15

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Huzhou Sinuo Home Textile Co.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015007646. Last updated year: 2026. Please use registration number 3015007646 when referencing this establishment in official correspondence.