Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680934

FEI Number

3006993165

Entity Name

SUZHOU HENGXIANG IMP. & EXP. CO., LTD

City/State/Country

SUZHOU Jiangsu, CN

Establishment Address

18TH FL.INTERNATIONAL ECONOMY, AND TRADE BUILDING, 1638 XIHUAN RD., SUZHOU Jiangsu 215004, CN

Establishment Type(s)

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

Owner / Operator

SUZHOU HENGXIANG IMP. & EXP. CO., LTD (Owner Number: 9010435)

Owner / Operator Contact Address

18TH FL.INTERNATIONAL ECONOMY, & TRADE BUILDING, 1638 XIHUAN RD., SUZHOU,, CN-JS 215004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gauze Sponge, Nonresorbable for External Use, Tracheostomy Dressing Shoe Cover, Booties, SHOECOVERS Identification Wristbands,ID BRACELET NON WOVEN TAPE, SILK TAPE, MEDICAL TAPE, SURGICAL TAPE ENDOSCOPE CLEANING BRUSH cleaning brush Face Mask, ear-loop, Non-woven Face Mask, Procedure Mask URINARY DRAINAGE BAGS Urinary Drainage Bags, Sterile Urinary Leg Bags, 600cc or 1000cc, Sterile Advantage Urinary Bags, Sterile Frist Aid Kit Plastic Towel Clamp lemon glycerin swabs sterile Allicator,absorbent tipped ,Sterile Cotton applicators sterile Underpad bedding, Medical Underpad, Disposible Underpad, UNDER PAD, BODY BAG EXAM GOWN, ISOLATION GOWN Urine Bag, Leg Bag Cap, Disposable Nonwoven cap Fine Point Acupuncture Needles Alpha Acupuncture Needles, acupuncture needles Cotton Balls,Cotton Rolls,Cotton Strings,Cotton Pleats,Dental Cotton Rolls Adult toothbrush,Kids toothbrush Face Mask; Dust Mask; Carbon Mask, Paper or Non-woven First Aid Kit without Drug Bandage, Cast TDP Lamp Precision TDP Lamp Surgical Cap, Hair nets, Hairnet Cap, surgical, CPE GOWN Cotton Swabs Irrigation Syringe Sterile Leg Bag for Urine Collection Feeding Bags,Enteral Delivery Pump Bag Set Disposable Nonwoven Isolation Gown, GOWN Elastic Bandage Apron, Adult Bibs, Protective Apron

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2009-08-18
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2006-03-08
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2019-03-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2006-03-08
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-11-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2009-09-24
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2014-05-14
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-11-19
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2008-09-24
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-10-13
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2014-02-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2010-07-21
FME	Gown, Examination	General Hospital	Class 1	880.6265	2006-07-06
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-07-06
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2026-04-13
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2012-11-28
EFN	Cotton, Roll	Dental	Class 1	872.6050	2020-05-14
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-07-07
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2012-01-16
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2008-09-24
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2006-03-08
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2011-10-05
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-07-21
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2007-07-02
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2012-11-06
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-05-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-02-27
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-05-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-10-27
IWO	Apron, Protective	Radiology	Class 1	892.6500	2010-07-21

Official Correspondent

ZHONG WEI

US Agent Details

Brenda Rojas Business: Busse Hospital Disposables Email: brojas@busseinc.com Phone: (631) 4354711

Related Public Records

Same Entity

SUZHOU HENGXIANG IMP. & EXP. 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680934. Last updated year: 2026. Please use registration number 9680934 when referencing this establishment in official correspondence.