Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009290468

FEI Number

3009290468

Entity Name

SUZHOU EMY MEDICAL SUPPLIES CO.,LTD.

City/State/Country

ChangShu Jiangsu, CN

Establishment Address

ChangBang Road,RenYang Town, ChangShu Jiangsu 215539, CN

Establishment Type(s)

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

Owner / Operator

SuZhou Emy Medical Supplies Co.,Ltd. (Owner Number: 10037155)

Owner / Operator Contact Address

ChangBang Road,RenYang Town, ChangShu, CN-JS 215539, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bandage, Cast - Orthopedic Casting Tape Component, Cast - cast Padding Emergency Blanket Dressing,Wound,Hydrophilic - Alginate Non-Wovens; Alginate Wound Dressing Oral swab Splint, Traction - Orthopedic Splint Gel Pack Medical Tape, Tubular Bandage Gauze/Sponge,Nonresorbable For External Use - EPBD; Multi Purpose Burn Bandage First aid kits Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-03-13
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2011-06-22
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-03-08
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-04-20
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2018-09-16
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2014-03-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-08-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-03-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-04-20
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2023-03-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-03-08

Official Correspondent

Lixin Zhou

US Agent Details

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

Related Public Records

Same Entity

SuZhou Emy Medical Supplies Co.,Ltd.

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
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009290468. Last updated year: 2026. Please use registration number 3009290468 when referencing this establishment in official correspondence.