Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013564290

FEI Number

3013564290

Entity Name

YANGZHOU ZHILIN SPORTS ITEMS CO., LTD

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

Zhaoxian Road Shanian Tangzhuang, Town Gaoyou, Yangzhou Jiangsu 222002, CN

Establishment Type(s)

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

Owner / Operator

Yangzhou Zhilin Sports Items Co., Ltd (Owner Number: 10054965)

Owner / Operator Contact Address

Zhaoxian Road Shanian Tangzhuang, Town Gaoyou, Yangzhou, CN-JS 222002, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

protector, ostomy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-10-13
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2017-07-28
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-10-13
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2024-09-25
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2019-04-09
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-05-18
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-10-13
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-01-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Yangzhou Zhilin Sports Items 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 3013564290. Last updated year: 2026. Please use registration number 3013564290 when referencing this establishment in official correspondence.