13YRSHangzhou Fushan Medical Appliances Co., Ltd.
Supplier
This supplier has been verified onsite by world-leading inspection company,
SGS Group
Verified onsite by world-leading inspection company, SGS Group
2019.02.24
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Hangzhou Fushan Medical Appliances Co., Ltd., located in the scenic Linglong Industrial Park of Hangzhou City, was established in July 2005.Covering an area of 10,000 sqms, Fushan, as a manufacturer of silicone and plastic disposables with standard clean room of class 100,000, was designed and constructed totally in accordance with GMP standards and requirements, equipped with leading international production and testing machines of silicone products. Our company has a strong R&D and quality control team with experienced engineers and technicians.In order to keep pace with world top level in manufacturing medical devices, our company imported advanced silicone liquid-injection molding machine system from France, which broke through the production bottleneck of high-quality implanted products. We also have brought in a large Ethylene Oxide Sterilization Cabinet which meet CE standard, to ensure the safety of sterile products, and to provide accurate verification reports. With the wide scope of business range including Silicon Foley Catheter, Microwave Catheter, Miniature Infusion, Silicon Reservoir and Silicone Drainage System, Infusion Pump, Laryngeal Mask Airway from the first generation to the fourth generation, SLIPA Airway, common and special infusion sets, High Frequency Electronic and microwave therapy apparatus, our company has developed into an enterprise group, consisting of the following Subsidiaries:A.Hangzhou Fushan Medical Appliances Co., LTD. The sales headquarter of the group and it also specializes in researching, developing and producing medical-silicone disposables. It's also the sole prescribed distributor in China of SLIPA MEDICAL LTD., UK.B. Beijing Boyikang Technology Co., LTD. It specializes in researching, producing and marketing products of medical electronic products.C.Jiaxing Tongcheng Medical Appliances Co.,LTD.The sales headquarter of the group and it also specializes in researching, developing and producing medical-plastic disposables.Fushan Medical Chronicle of Events:1)This facility land of 10000sqm was bought in April,2005.2)The factory construction started in Dec.2005.3)The Workhouse building and Comprehensive Building finished in Jan.2007; main production machines and equipment arrived in 2007.4)Fushan Group's headquarter moved to Fushan in 2007.5)Finish main products molds developed in 2008.6)Fushan got CE certificate and ISO13485 approval in2008,registered in FDA.7)Attended the first CMEF in Oct.2008 and MEDICA2008 Fair in Nov.2008, starts to do Export.8)Started several Patented products manufacturing for some clients from USA and UK in 2009. 9)Fushan Medical was awarded as 'National Hi-Tech Enterprise' in 2010.10)Fushan passed the GMP audit carried by CFDA in 2011.11)Fushan built a new building for plastic disposable workhouses.
5.0/5
Very satisfied
1 Reviews
  • Transaction level
  • 13 Transactions
    280,000+
  • Response Time
    24h-48h
  • Response Rate
    67.7%
Business Type
Manufacturer, Trading Company
Location
Zhejiang, China (Mainland)
Main ProductsOwnership
Private Owner
Total Employees
201 - 300 People
Total Annual Revenue
confidential
Year Established
2005
Certifications(1)
Product Certifications(3)Patents
-
Trademarks(1)Main Markets

PRODUCT CAPACITY

Production Flow

Production Equipment

Name
No
Quantity
Verified
Silicone Extrusion Machine
N/A
5
Silicone Injection Machine
N/A
12
Ethylene Oxide Sterilizer
N/A
1
Pad Printer
N/A
5
Drying Oven
N/A
4
Plastic Injection Molding Machine
N/A
14
Plastic Extrusion Machine
N/A
2
Plastic Blow Molding Machine
N/A
1
Verified

Factory Information

Factory Size
10,000-30,000 square meters
Factory Location
No. 1288, South Jinxi Road, Linglong Industrial Park, Lin'an District, Hangzhou City, Zhejiang Province, China
No. of Production Lines
5
Contract Manufacturing
OEM Service OfferedDesign Service OfferedBuyer Label Offered

Annual Production Capacity

Product Name
Production Line Capacity
Actual Units Produced(Previous Year)
Verified
Laryngeal Mask Airway
80000 pcs per month
400000 pcs
Feeding Tube / PEG
50000 pcs per month
420000 pcs
Silicone Drains
40000 pcs per month
250000 pcs
CVC
50000 pcs per month
300000 pcs
Needle-Free Connector
100000 pcs per month
500000 pcs
Verified

QUALITY CONTROL

Test Equipment

Machine Name
Brand & Model NO
Quantity
Verified
Gas Chromatograph
N/A
1
Medical Injection Needle Piercing Force Tester
N/A
1
Medical Injection Needle Stiffness Tester
N/A
1
Medical Injection Needle Toughness Tester
N/A
1
Tension Tester
N/A
1
Multifunction Testing Instrument
N/A
1
Verified

R&D CAPACITY

Production Certification

Picture
Certification Name
Certified By
Business Scope
Available Date
Verified
CE
TUV SUD
2018-07-16 ~ 2023-07-15
CE
TUV SUD
2018-11-15 ~ 2023-07-15
CE
TUV SUD
2018-11-16 ~ 2023-05-29
Verified

Certification

Picture
Certification Name
Certified By
Business Scope
Available Date
Verified
ISO13485
TUV SUD
Design and Development, Production and Distribution of PEG Kit, Drainage Kit. Production and Distribution of Silicone Urethral Catheter, Silicone Reservoir, Laryngeal Mask Airway, Lacrimal Dilation Tube, Miniature Infusion Pump, Oxygen Tube, Silicone Urinary Catheter, Rectal Tube, Stomach Tube, Nasogastric Tube, Trocar, Tracheal Tube, Drainage Tube, Nebulizer, Supra Laryngeal Airway, Mask, Urine Bag, Suction Tube Kit, Yankauer Handle, Resuscitator, Guedel/Oropharyngeal Airway, Intravenous Catheter, Infusion Access Adapter, Gastrostomy Tube, Enteral Feeding Bag, Breathing Trainer, Stoma Stoppers.
2018-11-15 ~ 2020-06-30
ISO Certificate
TUV SUD
EN ISO13485:2003/AC:2009
2011-07-01 ~ 2014-06-30
Verified

Trademarks

Picture
Trademark No
Trademark Name
Trademark Category
Available Date
Verified
Fushan
Verified

Research & Development

11 - 20 People