Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010881832

FEI Number

3010881832

Entity Name

Nantong MedTech Medical Products Co., Ltd.

City/State/Country

Nantong Jiangsu, CN

Establishment Address

18 Hongqiao Rd Xindian Town, Rudong County, Nantong Jiangsu 226432, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Nantong MedTech Medical Products Co., Ltd. (Owner Number: 10046844)

Owner / Operator Contact Address

18 Hongqiao Rd Xindian Town, Rudong County, Nantong, CN-JS 226432, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tzoar White Foam Dressing 6x4 Superabsorbent Dressing Island Dressings Healqu Skin Closure Strips Transparent Dressings Reinforced IV Transparent Dressings Shower protector Incise Drapes FIXAPRO Island Dressings extriCARE 2400 Negative Pressure Mini Oval Bandage extriCARE NPWT Sacral Bandage extriCARE 2400 Negative Pressure Small Oval Bandage extriCARE NPWT Incision Management Bandage extriCARE Gel Strip extriCARE 2400 Negative Pressure Large Oval Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-05-21
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2024-07-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-05-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2014-05-21

Official Correspondent

Fengjiao Zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: Regrek.Cs@Hotmail.Com Phone: (302) 6089028

Related Public Records

Same Entity

Nantong MedTech 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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010881832. Last updated year: 2026. Please use registration number 3010881832 when referencing this establishment in official correspondence.