Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006787036

FEI Number

3006787036

Entity Name

Hangzhou Fushan Medical Appliance Co., Ltd.

City/State/Country

Hangzhou City Zhejiang, CN

Establishment Address

No.1288 South Jinxi Road, Linglong Industrial Park, Lin'an District, Hangzhou City Zhejiang 311301, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hangzhou Fushan Medical Appliance Co., Ltd. (Owner Number: 10022911)

Owner / Operator Contact Address

No.1288 South Jinxi Road, Linglong Industry Park, Lin'an, Hangzhou, CN-ZJ 311301, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Digital Sensor Sleeves Bitewing Tabs gloves Nasal Oxygen Cannula Outflow Tubing Fluid Management Pack BOTTLE JD-HOOK Safety Stylet Accessory Durrani PVC Chest tube Kit, JD-1000 Chest Drainage Kit JD-1000 Amsino Silicone Catheter pack,tray URETERAL CATHETER foley catheter needle endoscope needle medical item pack,tray gauze silicone foley catheter Durrani Silicone Chest Tube Kit, JD-3000 Durrani General Purpose Silicone Drainage Catheter Kit, JD-2000 Endotracheal Tube Stylet Laryngeal Mask Airway Endotracheal Tube bedding seal Silicone Foley Catheter IRRIGATION Nasal Tube, Snare, lubricant Primo Lacto Silicone Round Fluted Drain, Silicone Round Drain, 10Fr-18Fr Silicone Blake Drain,10Fr,15Fr,19Fr,24Fr; Silicone Reservoir,100cc 200cc Silicone Flat Drain,7mm 10mm Silicone Flat Fluted Drain Perforated Hubless Flat Silicone Wound Drain 7mm, 10mm, 13mm, 14mm, Silicone Flat Channel Drain Wound Drain with Trocar 8mm 11mm 13mm silicone wound drainage system with trocar Perforated Round Silicone Wound Drain with adapter 10Fr 12Fr 14Fr 16Fr 18Fr Silicone Channeled Drian with Trocar 10Fr 15Fr 19Fr 24Fr silicone Reservoir 100cc 200cc 150cc 400cc Perforated Hubless Flat Silicone Wound Drain with adapter 7mm NEBULIZER, Nebulizer Mask Kit Oxygen Mask Summit Medical Catheter Balloon Catheter,Silicone Epistaxis Nasal Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2011-03-22
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2018-12-28
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2012-02-22
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2024-07-04
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2012-02-22
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2024-01-03
OAJ	Catheter, Drainage, Intraoral/Extraoral	General, Plastic Surgery	Class 1	878.4200	2023-10-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2011-03-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-02-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-02-22
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2007-10-21
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-02-22
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2011-03-22
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2011-03-22
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2011-03-22
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2014-04-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-02-22
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2012-02-22
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2012-02-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-02-22
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2007-10-21
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2018-12-28
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2008-08-06
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-02-22
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2011-03-22
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-02-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-02-22
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-12-07
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2012-02-22
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2016-07-28
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-04-09
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2021-01-13
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-10-21
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2012-02-14

Official Correspondent

Heather Qin

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Fushan Medical Appliance 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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006787036. Last updated year: 2026. Please use registration number 3006787036 when referencing this establishment in official correspondence.