Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004022422

FEI Number

3004022422

Entity Name

SHANGHAI ISO MEDICAL PRODUCTS CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

999 LIUCHEN ROAD, PUDONG NEW AREA, SHANGHAI 201202, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHANGHAI ISO MEDICAL PRODUCTS CO., LTD. (Owner Number: 9056122)

Owner / Operator Contact Address

999LIUCHEN ROAD PUDONG NEW AREA, SHANGHAI, CN-SH 201202, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

extriCARE NPWT Drape - One Adhesive Drape extriCARE Small Foam Kit extriCARE Large Foam Kit extriCARE 3600 400cc Canister extriCARE NPWT Drape - Two Adhesive Drape extriCARE2400 NPWT System extriCARE NPWT Drape COVERSTRIP; LEUKOSTRIP; LEUKOSTRIP S Transparent Film Dressing HALYARD Transparent Film Dressing MEDICHOICE Transparent Film Dressing Transparent Dressing TRANSPARENT WATERPROOF DRESSING HALYARD Transparent Dressing Medline Incise Drape Island Dressings Silicone Superabsorbent Bordered Dressing Superabsorbent Dressing Hydrocolloid dressing Bordered Gauze Dressing Non-Woven Island Dressings with PU backing HydraLock SA Hydrocolloid Extra Thin Dressing XLR8+ Flat Port Purple Luer Unsterile XLR8 Port Dressing XLR8 Transparent Film Dressing XLR8/XLR8+TRANSPARENT FILM XLR8/XLR8+ Port A4-XLR8 Foam Dressing Polyurethane Dressing Foam Dressing Tzoar Small Oval Wound Dressing Tzoar Large Oval Wound Dressing Tzoar Rectangular Wound Dressing One Adhesive Drape Silicone Clear Dressing Silicone Mesh MEDICHOICE Adhesive Island Dressing Transparent dressing HALYARD Non-Adherent Dressing Melolite Silicone Gel Foam Dressing Areza Transparent Adhesive Film Dressing Transparent Film Dressing Silicone Wound Contact Layer Dressing HALYARD Adhesive Island Dressing MEDICHOICE Non-Adherent Dressing Silicone Foam Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-06-13
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2023-12-05
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2015-03-09
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-07-30
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-11-14
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-11-27
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-07-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2009-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

Anny zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

SHANGHAI ISO 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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).
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004022422. Last updated year: 2026. Please use registration number 3004022422 when referencing this establishment in official correspondence.