FDA Registration
Active
🇨🇳 China
FESUN SHANGHAI CO., LTD.
Reg #: 3017896419
·
FEI: 3017896419
·
Expires 2026
Products
31
Proprietary Names
31
Establishment Types
3
Classifications
31
Registration Details
- Registration Name
- FESUN SHANGHAI CO., LTD.
- Registration Number
- 3017896419
- FEI Number
- 3017896419
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 702, No. 19, Sifeng Road, Sijing Town, Songjiang District
- City
- shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K140237
Owner / Operator
- Firm Name
- Fesun Shanghai Co., Ltd.
- Operator Number
- 10079407
- Address
- Room 702, No. 19, Sifeng Road, Sijing Town, Songjiang District
- City
- shanghai
- State
- CN-SH
- Postal Code
- 200020
- Country
- CN
- Correspondent
- Kevin Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2026-05-12 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | Class 1 | General Hospital | No | 2026-05-12 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2024-01-04 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2022-01-29 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2022-01-29 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2022-01-29 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2026-01-08 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2022-01-29 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2025-12-08 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-11-21 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2022-01-29 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2024-06-12 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2026-05-12 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2022-01-29 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-06-17 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2022-01-29 |
| Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile | NNY | Class 1 | Gastroenterology, Urology | No | 2026-05-12 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-01-29 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2022-01-29 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-03-25 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-01-29 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-01-29 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2022-01-29 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2022-01-29 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-05-12 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2026-05-12 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2026-05-12 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-11-21 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2022-01-29 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2022-01-29 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2020-12-04 |
Proprietary Names
Healing bandage
Medical tape
DRESS, SURGICAL
NURSING PAD,POLYURETHANE PAD WITH STARCH COPOLYMER,GLYCERIN,AND SURFACTANT(F-68)
Kit, surgical instrument, disposable
GARMENT, PROTECTIVE, FOR INCONTINENCE
Container,Liquid Medication,Graduated, Medicine Cups 1g;Medicine Cups 1.2g, Medicine Cups 1.4g, Medicine Cups 1.6g;Medicine Cups 1.8g
FIBER,MEDICAL,ABSORBENT
Pill crusher/cutter
Gauze / sponge,nonresorbable for external use
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
NAP pads, non-adherent pad
ostomy bag
SYRINGE, IRRIGATING (NON DENTAL)
ACCESSORY,SURGICAL APPAREL
TOOTHBRUSH,MANUAL
Condom Catheter, External Catheter, Rusch Male Exeternal, Catheter
BEDDING,DISPOSABLE,MEDICAL
Enema kit
PACK, HOT OR COLD, DISPOSABLE
CANNULA, NASAL, OXYGEN
MASK, OXYGEN
Pad,menstrual, unscented
nebulizer mask
medical adhesive tape
Isolation gown
Liquid protective dressing
Drape, surgical, exempt
COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
GOWN,ISOLATION,SURGICAL
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)