Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010398927

FEI Number

3010398927

Entity Name

JIANGYIN HESTIA TEXTILES CO., LTD.

City/State/Country

Jiangyin City Jiangsu, CN

Establishment Address

No.18 Xinya Road, Zhutang Town, Jiangyin City Jiangsu 214400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangyin Hestia Textiles Co., Ltd. (Owner Number: 10044350)

Owner / Operator Contact Address

No.18 Xinya Rd, Zhutang Town, Jiangyin City, CN-JS 214400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FIBER,MEDICAL,ABSORBENT Skin Pressure Protector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2020-04-30
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-05-30
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2026-01-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-10-15

Official Correspondent

Zhou Hongjie

US Agent Details

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

Related Public Records

Same Entity

Jiangyin Hestia Textiles Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010398927. Last updated year: 2026. Please use registration number 3010398927 when referencing this establishment in official correspondence.