Hangzhou Fushan Medical Appliance Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 44 device types.
Hangzhou Fushan Medical Appliance Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Retractor, Arthroscope and 42 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006787036 |
| FEI number | 3006787036 |
| Establishment type | Contract manufacturer, Reprocessor, Contract steriliser, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 杭州富善医疗器械有限公司 |
|---|---|
| Unified social credit code | 913301857766107466 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No.1288 South Jinxi Road, Linglong Industrial Park |
| Postal code | 311301 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Ureteral Catheter | Class 1 | foley catheter, Ureteral Catheter | 2007 | 5 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Laryngeal Mask Airway, Endotracheal Tube | 2008 | 84 |
| Anoscope And Accessories | Class 2 | 2012 | 3 | |
| Applicator, Absorbent Tipped, Sterile | Class 1 | applicator | 2012 | 100 |
| Arthroscope | Class 2 | Irrigation, Silicone Foley Catheter | 2012 | 21 |
| Balloon, Epistaxis | Class 1 | Balloon Catheter,Silicone, Epistaxis Nasal Catheter, Summit Medical Catheter | 2012 | 6 |
| Bedding, Disposable, Medical | Class 1 | bedding | 2012 | 308 |
| Bottle, Collection, Vacuum | Class 2 | Outflow Tubing, Fluid Management Pack, Bottle | 2012 | 88 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal Oxygen Cannula | 2024 | 97 |
| Catheter And Tip, Suction | Class 2 | Onetrac LXS, Yankauer | 2021 | 70 |
| Catheter, Balloon Type | Class 1 | silicone foley catheter, Durrani General Purpose Silicone Drainage Catheter Kit, JD-2000, Durrani Silicone Chest Tube Kit, JD-3000 | 2007 | 4 |
| Catheter, Drainage, Intraoral/Extraoral | Class 1 | JD-1000, Chest Drainage Kit | 2023 | 3 |
| Catheter, Irrigation | Class 1 | Perforated Hubless Flat Silicone Wound Drain 7mm, 10mm, 13mm, 14mm,, Silicone Channeled Drian with Trocar 10Fr 15Fr 19Fr 24Fr, Perforated Hubless Flat Silicone Wound Drain with adapter 7mm, silicone wound drainage system with trocar, Silicone Flat Channel Drain Wound Drain with Trocar 8mm 11mm 13mm, silicone Reservoir 100cc 200cc 150cc 400cc and 1 more | 2021 | 24 |
| Catheter, Retention Type, Balloon | Class 2 | Amsino Silicone Catheter | 2011 | 17 |
| Catheter, Ventricular, General & Plastic Surgery | Class 1 | JD-HOOK Safety Stylet Accessory, Durrani PVC Chest tube Kit, JD-1000 | 2024 | 7 |
| Device, Intravascular Catheter Securement | Class 1 | Dialysis Catheter Dressing, Catheter Fixing dressing, Catheter Dressing, Central Venous Catheter Dressing | 2019 | 33 |
| Disinfectant, Medical Devices | Class 1 | medical item | 2012 | 197 |
| Drape, Surgical, Antimicrobial | Class 2 | drape | 2012 | 39 |
| Endoscope Channel Accessory | Class 2 | endoscope | 2011 | 21 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | gauze | 2012 | 266 |
| Holder, Film, X-Ray | Class 1 | Digital Sensor Sleeves, Bitewing Tabs | 2018 | 40 |
| Hysteroscope (And Accessories) | Class 2 | endoscope | 2011 | 13 |
| Hysteroscope Accessories | Class 1 | seal | 2011 | 11 |
| Laparoscope, Gynecologic (And Accessories) | Class 2 | endoscope | 2011 | 7 |
| Laryngoscope, Rigid | Class 1 | 2014 | 44 | |
| Lubricant, Patient | Class 1 | lubricant | 2012 | 33 |
| Mask, Oxygen | Class 1 | Oxygen Mask, Nebulizer Mask Kit, Nebulizer, | 2007 | 126 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizer Kit, Nebulizer Mask Kit, Nebulizer Mask, Nebulizer, | 2020 | 57 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | needle | 2012 | 9 |
| Needle, Hypodermic, Single Lumen | Class 2 | pack,tray, needle | 2012 | 71 |
| Operating Room Accessories Table Tray | Class 1 | pack,tray | 2012 | 25 |
| Protector, Ostomy | Class 1 | 2016 | 33 | |
| Pump, Breast, Non-Powered | Class 1 | Primo Lacto | 2016 | 33 |
| Retractor | Class 1 | 2015 | 34 | |
| Retractor, Vaginal | Class 1 | 2015 | 8 | |
| Snare, Nasal | Class 1 | Nasal Tube, Snare, | 2016 | 2 |
| Speculum, Vaginal, Nonmetal | Class 2 | 2011 | 40 | |
| Staple, Implantable | Class 2 | SubQ It! Bioabsorbable Skin Closure System – Stapler | 2017 | 16 |
| Stapler, Skin | Class 1 | SubQ It! Bioabsorbable Skin Closure System – Stapler | 2017 | 22 |
| Stylet, Tracheal Tube | Class 1 | Endotracheal Tube Stylet | 2018 | 34 |
| Syringe, Piston | Class 2 | pack,tray | 2012 | 60 |
| System, Irrigation, Urological | Class 2 | Irrigation, Silicone Foley Catheter | 2012 | 8 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | Silicone Reservoir,100cc 200cc, Silicone Round Drain, 10Fr-18Fr, Silicone Blake Drain,10Fr,15Fr,19Fr,24Fr;, Silicone Flat Drain,7mm 10mm, Silicone Flat Fluted Drain, Silicone Round Fluted Drain, | 2013 | 23 |
| Vinyl Patient Examination Glove | Class 1 | gloves | 2012 | 72 |
Clearances
No clearance names Hangzhou Fushan Medical Appliance Co., Ltd. as applicant. 7 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K042893 | 2005-03-11 | KKX | Traditional | Intl. Medsurg Connection, Inc. |
| K030927 | 2003-04-17 | LYZ | Traditional | Copioumed International, Inc. |
| K023808 | 2003-03-10 | LJH | Traditional | Intl. Medsurg Connection, Inc. |
| K022159 | 2002-11-07 | FMF | Traditional | Intl. Medsurg Connection, Inc. |
| K990519 | 2000-06-02 | BSP | Traditional | Myco Medical Supplies, Inc. |
| K871169 | 1987-04-01 | KMJ | Traditional | H & P Industries, Inc. |
| K771203 | 1977-07-14 | FMI | Traditional | Terumo America, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Anesthesia series, Gastroenterology series, Surgical drainage series, Urology series, Gynecology series |
| Certifications | CE, FDA |
| Export markets | Multiple international markets |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.