Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010149039

FEI Number

3010149039

Entity Name

FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.8 ChangYang Road, Wujin Economic Development Zone, Changzhou Jiangsu 213145, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD (Owner Number: 10042166)

Owner / Operator Contact Address

No.8 ChangYang Road, Wujin Economic Zone, Changzhou, CN-JS 213 145, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Presto Inflation Device INVIA FITPAD CoPilot VL Introducer (Bougie) Venner A.P. Advance Video Laryngoscope Blade Urine Collection Container NIM Essence EMG Endotracheal Tube M1 Capnography Mask Copilot VL Disposable Sheath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-02-06
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-07-18
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2012-10-27
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2012-10-27
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2016-10-16
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-12
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-07-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-07-21
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-10-27

Official Correspondent

Kelly Chen

US Agent Details

Mark Gauvain Email: mark.gauvain@forefrontmedical.com Phone: (978) 8042279

Related Public Records

Same Entity

FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
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
3007361214	SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.	Shenzhen Guangdong, CN
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
1526863	ICU Medical, Inc.	DUBLIN, OH, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010149039. Last updated year: 2026. Please use registration number 3010149039 when referencing this establishment in official correspondence.