Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011669217

FEI Number

3011669217

Entity Name

SHANGHAI FLY MEDICAL DEVICES CO., LTD.

City/State/Country

Minhang District Shanghai, CN

Establishment Address

4th Floor, Building No. 3, Block No.1, No. 3279 Sanlu Road, Minhang District Shanghai 201112, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai FLY Medical Devices Co., Ltd. (Owner Number: 10062948)

Owner / Operator Contact Address

4th Floor, Building No. 3, Block No.1, No. 3279 Sanlu Road, Minhang District, CN-SH 201112, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bulb, Inflation, For Endoscope Water-Based Lubrication Light, Examination, Medical, Battery Powered Depressor, Tongue, Non-Surgical trocar cleaning swab Disposable Anal Manual Nebulizer Plastic Tube Silicon Tubing;Silicone rubber tubing Tubing, Pressure And Accessories Face mask Camera Vagina Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-03-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-03-14
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2020-03-14
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2020-03-14
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-03-14
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2020-03-14
EPN	Pump, Nebulizer, Manual	Ear, Nose, Throat	Class 1	874.5220	2021-10-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2020-03-14
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2026-05-08
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-14
FWC	Camera, Television, Surgical, With Audio	General, Plastic Surgery	Class 1	878.4160	2020-03-14
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2020-03-14

Official Correspondent

Gang Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai FLY Medical Devices 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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3033589330	Merit Medical Australia Pty Ltd.	Braiside Victoria, AU
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
9610632	ROCKET MEDICAL PLC	WASHINGTON Sunderland, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011669217. Last updated year: 2026. Please use registration number 3011669217 when referencing this establishment in official correspondence.