Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014926389

FEI Number

3014926389

Entity Name

Jiangsu JianYu Health Medical Co., Ltd

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No. 88 Longxi Avenue, Zhulin Town, Jintan District, Changzhou City Jiangsu 213241, CN

Establishment Type(s)

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

Owner / Operator

Jiangsu JianYu Health Medical Co., Ltd (Owner Number: 10039161)

Owner / Operator Contact Address

No.88 Longxi Avenue, Zhulin Town, Jintan District, Changzhou City, CN-JS 213241, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Burn Sheet FLUID FIGHTER SUCTION MAT;SUCTION MAT;SUCTION RING; SUCTION RING WITH TUBING; Prophylaxis Cup round fluff sponges Medical Absorbent Fiber Medline Enteral Feeding Sets Amniotic Membrane Perforator Resin Applicator Yankauer; Suction Swab; Suction Toothbrush;Suction Handle ;Y-Connector;Suction Catheter;Nasal Aspirator Oral Care Kits Surgical, Sponge Stick and others Drape Surgical HOOK, GASTRO-UROLOGY Surgical Mask Brush, Scrub, Operating-Rooms Drain Glider Clamp, umbilical Sterile Umbilical cord clamp TotalFit External catheter; TotalFit External catheter + TotalSecure Securement Device SURGICAL GOWNS Umbilical Cord Clamp Clipper Cutter HOOK,AMNIO,PLASTIC,STERILE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2014-10-06
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2025-09-24
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2019-12-11
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2018-02-21
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2016-09-21
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2011-12-14
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-06-28
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2016-04-25
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2024-06-26
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2024-06-26
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2017-08-18
KXR	Applicator, Resin	Dental	Class 1	872.3140	2011-12-14
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2019-12-11
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2024-06-03
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2013-07-14
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2022-02-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-12-10
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2021-11-08
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-01-12
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-07-14
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2013-07-14
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2026-04-24
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2017-03-24
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2014-10-06
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2015-06-02
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2018-01-22
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-03-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-03-09
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2024-07-26
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2022-05-06

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Jiangsu JianYu Health Medical 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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014926389. Last updated year: 2026. Please use registration number 3014926389 when referencing this establishment in official correspondence.