Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037040712

FEI Number

3037040712

Entity Name

ECOLLINK NON-WOVEN COMPANY LIMITED

City/State/Country

HONGKONG, CN

Establishment Address

FLAT/RM 705, 7/F, YUEN COMM BLDG NO.75, FA YUEN STREET, MONG KOK, KL, HONGKONG 999077, CN

Establishment Type(s)

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

Owner / Operator

ECOLLINK NON-WOVEN COMPANY LIMITED (Owner Number: 10092879)

Owner / Operator Contact Address

FLAT/RM 705, 7/F, YUEN COMM BLDG NO.75, FA YUEN STREET, MONG KOK, KL, HONGKONG, CN-NOTA 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Boot Cover; Disposable Slipper; Shoe Cover; Sleeve Cover Beard Cover; GLOVES; Beard Cover Dressing/Visitor Gown/Clothing; Visitor Gown Cohesive Bandage Face Mask Disposable Bed Sheet; Disposable Pillow Cover Shoe Cover Disposable Hood Cap/Disposable Cap/Surgical Cap/Non Woven Cap; Nurse Cap; Surgical Cap; Worker Cap D388445 KME Disposable Bed Sheet; Disposable Dental Bibs CPE Gown; Isolation Gown; Pe Rain Coat; Work Cloth; Coverall Apron Patient Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2025-03-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-03-02
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-03-02
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-03-02
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2025-03-02
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-03-02
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2025-03-02
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2025-03-02
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-03-02
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2025-03-02
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2025-03-02
IWO	Apron, Protective	Radiology	Class 1	892.6500	2025-03-02
FME	Gown, Examination	General Hospital	Class 1	880.6265	2025-03-02

Official Correspondent

Xiuhe Liang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

ECOLLINK NON-WOVEN COMPANY LIMITED

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

View Entity Profile →

Similar Registrations

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3013429557	HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.	Heyuan City Guangdong, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037040712. Last updated year: 2026. Please use registration number 3037040712 when referencing this establishment in official correspondence.