FESUN SHANGHAI CO., LTD.

FDA Device Registration & Listing · shanghai, CN · Registration 3017896419

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017896419
FEI Number
3017896419
Entity Name
FESUN SHANGHAI CO., LTD.
City/State/Country
shanghai, CN
Establishment Address
Room 702, No. 19, Sifeng Road, Sijing Town, Songjiang District, shanghai 200020, CN
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Fesun Shanghai Co., Ltd. (Owner Number: 10079407)
Owner / Operator Contact Address
Room 702, No. 19, Sifeng Road, Sijing Town, Songjiang District, shanghai, CN-SH 200020, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2026-05-12
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use General Hospital Class 1 880.5240 2026-05-12
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2024-01-04
NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) General Hospital Class 1 880.5630 2022-01-29
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2022-01-29
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2022-01-29
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2026-01-08
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2022-01-29
OHY Pill Crusher/Cutter General Hospital Class 1 880.6430 2025-12-08
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2024-11-21
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2022-01-29
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2024-06-12
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 2026-05-12
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2022-01-29
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2022-06-17
EFW Toothbrush, Manual Dental Class 1 872.6855 2022-01-29
NNY Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2026-05-12
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2022-01-29
FCE Enema Kit Gastroenterology, Urology Class 1 876.5210 2022-01-29
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2025-03-25
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2022-01-29
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2022-01-29

Official Correspondent

Kevin Wang

US Agent Details

Israel Perlstein Email: rachel@kilo-promise.com Phone: (917) 6123842

Related Public Records

Same Entity

Fesun Shanghai Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number Establishment Name Location
3009067117 Posthorax Inc. Clearwater, FL, US
3010195489 TOYO RESIN CORPORATION FUJI Shizuoka, JP
3004740112 OVIK Health Columbus, NC, US
2182345 BIRD & CRONIN, LLC Eagan, MN, US
3042639641 SPLINTBOX Frontenac, MO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017896419. Last updated year: 2026. Please use registration number 3017896419 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.