Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014108257

FEI Number

3014108257

Entity Name

MEDSTAR HEALTHCARE CO.,LIMITED

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

DIPU INDUSTRIAL ZONE, ANJI COUNTY, HUZHOU CITY,ZHEJIANG,CHINA, Huzhou Zhejiang 313300, CN

Establishment Type(s)

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

Owner / Operator

MEDSTAR HEALTHCARE CO.,LIMITED (Owner Number: 10056421)

Owner / Operator Contact Address

DIPU INDUSTRIAL ZONE, ANJI COUNTY, HUZHOU CITY,ZHEJIANG,CHINA, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable surgical face mask, Protective mask RESCUE BLANKETS Dressing,Wound,Hydrophilic (Non-Adhesive Dressing (Pad) , Eye Pad) Bandage, Cast (Polymer And Fiberglass Casting Bandage) Cover, Limb (Stockinette, Tubular bandage) TAPE Alcohol pad gauze pad,gauze swab,gauze sponge Component, Cast (Under cast padding, Orthopedic cast padding) Conforming(Pbt) Bandage, Pop, Gauze Bandage, Pressure Bandage, Cold Bandage) Bandage, Elastic (Elastic Bandage, Crepe Bandage, Cohesive bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-03-10
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-12-07
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2017-12-07
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2017-12-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-03-10
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-12-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-01-09
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2017-12-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-12-07

Official Correspondent

XIANG Yan

US Agent Details

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

Related Public Records

Same Entity

MEDSTAR HEALTHCARE CO.,LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3041850200	RISKWISE SUPPLIES LLC	Lorton, VA, US
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3010141571	Xiantao Zhongyi Safety & Protection Products Co.,Ltd.	Xiantao City Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014108257. Last updated year: 2026. Please use registration number 3014108257 when referencing this establishment in official correspondence.