Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017610906

FEI Number

3017610906

Entity Name

XIAMEN LONGSTAR MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

5F, 87#, Huli Park, Tong an Industrial Concentration Area, Xiamen Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen LongStar Medical Equipment Co.,Ltd (Owner Number: 10078112)

Owner / Operator Contact Address

5F, 87#, Huli Park, Tong'an Industrial Concentration Area, Xiamen, CN-FJ 361100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthosis LIMB POST OP SHOE joint, ankle brace A12 ANKLE AIR WALKER BRACE - XL A12 ANKLE AIR WALKER BRACE - SMALL A12 ANKLE AIR WALKER BRACE - MEDIUM A12 ANKLE AIR WALKER BRACE - LARGE Walking Aid Hernia Belt Finger gloves Elbow & Hand splint Orthosis back and arm splint ORTHOSIS LUMBAR Hip Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2020-10-10
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2020-10-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2025-05-20
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2024-11-28
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2024-11-28
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2020-10-10
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2020-10-10
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2022-12-09
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2024-11-28

Official Correspondent

Anna Wu

US Agent Details

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

Related Public Records

Same Entity

Xiamen LongStar Medical Equipment 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 3017610906. Last updated year: 2026. Please use registration number 3017610906 when referencing this establishment in official correspondence.