Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015288041

FEI Number

3015288041

Entity Name

SUMEC TEXTILE CO.,LTD

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

68 Yunlongshan Road, Nanjing Jiangsu 210019, CN

Establishment Type(s)

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

Owner / Operator

SUMEC TEXTILE CO.,LTD (Owner Number: 10086869)

Owner / Operator Contact Address

68 Yunlongshan Road, Nanjing, CN-JS 210019, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mattress protector under pad Clothing protector Towel edema glove Medglide Patient gowns

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2022-12-18
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-01-07
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-01-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-09-25
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2026-06-03
FME	Gown, Examination	General Hospital	Class 1	880.6265	2025-01-07

Official Correspondent

Nancy Xie

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

SUMEC TEXTILE 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 3015288041. Last updated year: 2026. Please use registration number 3015288041 when referencing this establishment in official correspondence.