Fesun Shanghai Co., Ltd.

Registered establishment in Shanghai, China. 31 device types.

Registry build 21.09.26

Fesun Shanghai Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enema Kit, Mask, Oxygen and 29 other device types. Its earliest product listing with the FDA dates from 2020.

Registration

FDA registration record for Fesun Shanghai Co., Ltd.
Registered name FESUN SHANGHAI CO., LTD.
Status Registered
Registration expires 2026
Registration number 3017896419
FEI number 3017896419
Establishment type Contract manufacturer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Fesun Shanghai Co., Ltd.
Chinese legal name 上海菲尚贸易有限公司
Source customs registration record

Location

Address of Fesun Shanghai Co., Ltd.
City Shanghai
Province Shanghai
Address Room 702, No. 19, Sifeng Road, Sijing Town, Songjiang District
Postal code 200020
Country China

What It Makes

Device types Fesun Shanghai Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 Accessory,surgical Apparel 2022 439
Bag, Drainage, With Adhesive, Ostomy Class 1 ostomy bag 2026 49
Bag, Urine Collection, Leg, For External Use, Sterile Class 1 BAG, Urine Collection, LEG, FOR External USE, Sterile 2022 52
Bandage, Cast Class 1 Healing bandage 2026 81
Bedding, Disposable, Medical Class 1 Bedding,disposable,medical 2022 308
Cannula, Nasal, Oxygen Class 1 Cannula, Nasal, Oxygen 2022 97
Collector, Urine, (And Accessories) For Indwelling Catheter Class 2 Collector, Urine, (AND Accessories) FOR Indwelling Catheter 2022 51
Container, Liquid Medication, Graduated Class 1 Container,Liquid Medication,Graduated, Medicine Cups 1g;Medicine Cups 1.2g, Medicine Cups 1.4g, Medicine Cups 1.6g;Medicine Cups 1.8g 2026 68
Drape, Surgical, Exempt Class 2 Drape, surgical, exempt 2024 107
Dress, Surgical Class 1 Dress, Surgical 2024 71
Dressing, Wound, Hydrogel Without Drug And/Or Biologic Class 1 Liquid protective dressing 2026 118
Dressing, Wound, Hydrophilic Class 1 NAP pads, non-adherent pad 2024 195
Enema Kit Class 1 Enema kit 2022 24
Fiber, Medical, Absorbent Class 1 Fiber,medical,absorbent 2022 172
Garment, Protective, For Incontinence Class 1 Garment, Protective, FOR Incontinence 2022 181
Gauze / Sponge,Nonresorbable For External Use Class 1 Gauze / sponge,nonresorbable for external use 2024 266
Gown, Isolation, Surgical Class 2 Gown,isolation,surgical 2020 21
Kit, Surgical Instrument, Disposable Class 1 Kit, surgical instrument, disposable 2022 67
Mask, Oxygen Class 1 Mask, Oxygen 2022 126
Nebulizer (Direct Patient Interface) Class 2 nebulizer mask 2022 42
Non-Surgical Gown Class 1 Isolation gown 2026 318
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) Class 1 Nursing Pad,polyurethane PAD With Starch Copolymer,glycerin,and SURFACTANT(F-68) 2022 48
Pack, Hot Or Cold, Disposable Class 1 Pack, HOT OR Cold, Disposable 2025 176
Pad, Menstrual, Unscented Class 1 Pad,menstrual, unscented 2022 132
Pill Crusher/Cutter Class 1 Pill crusher/cutter 2025 41
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile Class 1 Condom Catheter, External Catheter, Rusch Male Exeternal, Catheter 2026 4
Syringe, Irrigating (Non Dental) Class 1 Syringe, Irrigating (NON Dental) 2022 110
Tape And Bandage, Adhesive Class 1 medical adhesive tape 2026 353
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use Class 1 Medical tape 2026 13
Toothbrush, Manual Class 1 Toothbrush,manual 2022 244
Tube, Aspirating, Flexible, Connecting Class 2 Tube, Aspirating, Flexible, Connecting 2022 51

Clearances

No clearance names Fesun Shanghai Co., Ltd. as applicant. 2 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.

510(k) clearances naming Fesun Shanghai Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K171535 2018-02-15 FYC Traditional Jingzhou Haixin Green Cross Medical Products Co., Ltd.
K140237 2015-01-08 CAF Traditional Suzhou Weikang Medical Apparatus Co., Ltd.

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
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Infitek Co., Ltd. 49
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Arthrex (Shanghai) Co., Ltd. 38
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Amsino Medical (Shanghai) Co., Ltd. 22
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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.

Where China Actually Supplies

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2,581device types they are registered for
340,248device records, each naming its maker
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