Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027517726

FEI Number

3027517726

Entity Name

Jiangsu Newvalue Medical Products Co., Ltd.

City/State/Country

Taizhou Jiangsu, CN

Establishment Address

No.22 Zelan Road, China Medical City, Taizhou Jiangsu 225300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Newvalue Medical Products Co., Ltd. (Owner Number: 10048334)

Owner / Operator Contact Address

No.22 Zelan Road, China Medical City, Taizhou, CN-JS 225300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skin Barrier Strips Skin Barrier Ring Skin Barrier Arc Pack, Hot or Cold, disposable (Hydrogel patch) Hydrogel Dressing Dressing, wound, hydrophilic (Alginate dressing) Intravascular Catheter Securement Hemostatic Dressing silicone scar sheets Silicone Scar Gel Self-Adherent Scar Care Dressing Skin Closure Strips SURECELL Gelling Fiber Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-10-27
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2014-12-30
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2026-01-19
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-12-30
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2018-04-25
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2024-04-22
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-06-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-04-22

Official Correspondent

Yan Shi

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Newvalue Medical Products 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3015300984	INNOVATION LABS, INC	Mahwah, NJ, US
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
3002807315	SYNERGY HEALTH STERILISATION UK LTD	Daventry Northamptonshire, GB
3037918935	Pharmamed SA.	Anderlecht Brussels-Capital Region, BE
3014195785	CLINISUPPLIES (NANJING) CO., LTD	Nanjing Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027517726. Last updated year: 2026. Please use registration number 3027517726 when referencing this establishment in official correspondence.