Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033858895

FEI Number

3033858895

Entity Name

Jiangsu Hongsheng Bioengineering Co., Ltd.

City/State/Country

Nantong Jiangsu, CN

Establishment Address

No. 2, No. 66 Shengde Road, Jianghai Joint Development Demonstration Zone, Tongzhou Bay, Nantong Jiangsu 226000, CN

Establishment Type(s)

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

Owner / Operator

Jiangsu Hongsheng Bioengineering Co., Ltd. (Owner Number: 10091766)

Owner / Operator Contact Address

No. 2, No. 66 Shengde Road, Jianghai Joint Development Demonstration Zone, Tongzhou Bay, Nantong, CN-JS 226000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pack, hot or cold, reusable SLING, ARM Catheter fixing device/Catheter fixation dressing MASK,OXYCEN urine collection bag/Ostomy bag TOURNIQUET,NONPNEUMATIC goggles Hemostatic forceps/FORCEPS/tweezers/Surgical scissors ABSORBENT TIPPED NON-STERILE/FIBER, MEDICAL, ABSORBENT Pad, alcohol, device disinfectant/Disinfectant, medical devices APPLICATOR Eye pad/Eye pad/PAD, EYE Eye Pad Paper diaper/Breast pad Ice bag pads Waist Support Belt Hydrocolloid Roll YHR01 Hydrocolloid Adhesive Bandages Medical Surgical Kit Medical Adhesive Tape Tubular Elastic Net Bandage Umbilical Hernia Support Patch Anti-Embolism Stockings ostomy barrier strips Cracked Skin Patch Cesarean Section Dressing First Aid Kit/First Aid Kit/First aid kit without drug /Personal protection kit First Aid Kit Hydrocolloid Roll YHR02 Hydrocolloid Roll Medical Puncture Kit Medical Blood Collection Kit Elastic Net Cap Silver Ag Foam Dressing Silver Ag Hydrocolloid Dressing Silver ion alginate Skin Repair Dressing Hyaluronic Acid Dressing Skin Liquid Dressing Chlorhexidine Gluconate l.V,Securement Dressing Silver ion hydrocolloid Silver ion foam CHG Antimicrobial Dressing (CHG: Chlorhexidine Gluconate) Hydrogel Dressing Chlorhexidine Gel Dressing Non-woven adhesive dressing / Waterproof film dressing / Hydrocolloid dressing / Alginate dressing / Foam dressing Burn dressing / Dressing, wound, hydrophilic PU film dressing roll / Wound dressing / Hydrogel dressing Foam Dressing Polyurethane foam dressing / Silver dressing / Silicone gel dressing / Non-woven dressing roll Medical Cooling Gel Sheet Blue Light Series Transparent Dressing Careli Silicone gel dressing Heel Foam Dressing Silver Ag Hydrogel Dressing Silicone Gel Hydrogel Dressing (Core: Hydrogel, Adhesive Layer: Silicone Gel) Resorbable Collagen Wound Dressing Pads Gauze /sponge,nonresorbable for external use Cotton swab/Cotton ball/Cotton roll/Cotton sheet Gauze dressing/Gauze sheets/Gauze roll/Non woven fabric sheets Alcohol pad/Wet wipe Careli Silicone sheeting Silicone Scar Gel Wound Closure Device/Wound Skin Closure Kit Alcohol cotton ball / Alcohol swab / Iodophor cotton ball / Iodophor cotton swab / Iodophor cotton tablet pimplepatches Cooling patch / Cooling patch / Minus sticker / Zipper Strip Skin Closure Acne patch / Cold compress / Acne patch / Spot patch / Blister patch / Non-stick mat / Abdominal pad Baby ear strips / Intramuscular patch / Anti-snoring patch / Pet mat / Pimple patch IV dressing / Scar Patch / Silicone Gel Patch / Infusion dressings Bandage (Band-Aids) / Waterproof Band-Aids / Hydrocolloid Band-Aids / Fever cooling patch Hot pack / Body warmer / Wound seal dressing Non-stick mat / Blood-sucking pad / Nursing mat / First aid blanket / Heel pads / Hydrocolloid foot pads Isolation gown/protective suit/Face mask/blindfold /Varicose venous socksMedical gloves/Medical shoe cover INSTRUMENT,SURGIC.AL.DISPOSABLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-10-31
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-10-31
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-10-31
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2024-10-31
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2024-10-31
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-10-31
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2024-10-31
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2024-10-31
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-10-31
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-10-31
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2024-10-31
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-10-31
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2024-10-31
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2024-10-31
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-10-31
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-10-31
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2026-06-17
KZR	Chromatography (Liquid, Gel), Clinical Use	Clinical Chemistry	Class 1	862.2260	2024-10-31
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2024-10-31
PNA	Evoked Photon Image Capture Device	Neurology	Class 1	882.1561	2024-10-31
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-06-18
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2024-10-31
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2024-10-31
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-10-31

Official Correspondent

Leyu Li

US Agent Details

Emilie Davis Email: safjiofewiwds@wilson.ntesmail.com Phone: (805) 5797288

Related Public Records

Same Entity

Jiangsu Hongsheng Bioengineering 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
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3037007193	SHANGHAI HUIZHOU INDUSTRIAL CO., LTD	Shanghai City District, CN
3031182683	NINGBO YAMAI INDUSTRY AND TRADE CO., LTD.	Yuyao Zhejiang, CN
3016711531	BRANCH IN PHU THO, THYGESEN TEXTILE VIETNAM COMPANY LIMITED	Yen Lap Commune Phu Tho, VN
3008384548	ACTIVE-ICE, INC.	Norman, OK, US
3002393819	MEDICAL SPECIALTIES OF CALIFORNIA LIMITED	Orpington Kent, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033858895. Last updated year: 2026. Please use registration number 3033858895 when referencing this establishment in official correspondence.