Data / Medical devices / China / Fesun Shanghai Co., Ltd.
Fesun Shanghai Co., Ltd.: FDA-registered device maker in shanghai, China, 2 510(k) clearances
Fesun Shanghai Co., Ltd. is registered with the FDA (registration 3017896419) in shanghai, China. It lists 31 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 15, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017896419
- Address
- Room 702, No. 19, Sifeng Road, Sijing Town, Songjiang District, shanghai, China, 200020
- Owner or operator
- Fesun Shanghai Co., Ltd. (10079407)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 4, 2020
- Registered through
- 2026
- Brand names listed
- ACCESSORY,SURGICAL APPAREL, BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE, BEDDING,DISPOSABLE,MEDICAL, CANNULA, NASAL, OXYGEN, COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER, Condom Catheter, External Catheter, Rusch Male Exeternal, Catheter, Container,Liquid Medication,Graduated, Medicine Cups 1g;Medicine Cups 1.2g, Medicine Cups 1.4g, Medicine Cups 1.6g;Medicine Cups 1.8g, DRESS, SURGICAL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pill Crusher/Cutter | OHY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile | NNY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| February 15, 2018 | K171535 | SURGICAL ISOLATION GOWN | FYC | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | accessdata.fda.gov |
| January 8, 2015 | K140237 | DISPOSABLE NEBULIZER SET | CAF | Substantially Equivalent | Suzhou Weikang Medical Apparatus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
- All makers of Garment, Protective, For Incontinence
- All makers of Bandage, Cast
- All makers of Container, Liquid Medication, Graduated
Updated February 15, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.