Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005405146

FEI Number

3005405146

Entity Name

SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.

City/State/Country

JIADING Shanghai, CN

Establishment Address

NO. 658 GAOCHAO ROAD, JIADING Shanghai 201803, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. (Owner Number: 9078499)

Owner / Operator Contact Address

NO. 658, GAOCHAO ROAD, JIADING, CN-SH 201803, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112057

PMA Number

N/A

All Registered Proprietary Names

Exel Injection Plug with Cap Bulb Syringe Enteral irrigation ring top syringe Irrigation flat top syringe SOL-M Oral Dispensing Syringe Oral Syringe Oral Dispensing Syringe Oral Dispenser Enteral irrigation thumb control syringe w/500ml graduate Irrigation tray w/thumb control syringe Enteral irrigation flat top syringe Syringe (Low Dead Space) with Safety Needle MEDLINE SYRINGES Exel I.V. Extension Set EXEL I.V. ADMINISTRATION SET Insulin Safety Syringe Disposable Needles SoftFil® EasyGuide; SoftFil® Precision Sol-Care Retractable Safety Syringes VitreJect® Syringe VitreJect® Ophthalmic Syringes Syringe with Safety Needle Sol-Care 0.5ml Retractable Safety Syringes with Fixed Needle EXEL 1ml Delivery Syringe Sol-Guard TB Safety Syringe Sol-Guard Insulin Safety Syringe DropSafe Insulin Safety Syringe Sterile Insuin Syringe Sterile Hypodermic Syringe for Single use with/without Ndl, INSULIN SYRINGE Syringes with needles Hypodermic needles Disposable Syringe without needle Sterile Hypodermic Needle for Single use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-05
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2013-04-01
QNQ	Low Dead Space Piston Syringe	General Hospital	Class 2	880.5860	2025-11-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-06-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2005-10-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-12-05
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2013-06-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-03-21
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-10-26
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2013-06-07
QNQ	Low Dead Space Piston Syringe	General Hospital	Class 2	880.5860	2026-03-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-03-23
QLY	Ophthalmic Syringe	General Hospital	Class 2	880.5860	2026-03-23
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2025-11-24
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-03-11
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2024-12-17
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2015-08-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-02-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-02-01

Official Correspondent

ZHANG WEIXIN

US Agent Details

Richard Chun Business: The Wood Burditt Group Email: rchun@woodburditt.com Phone: (847) 2347500

Related Public Records

Same Entity

SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP 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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005405146. Last updated year: 2026. Please use registration number 3005405146 when referencing this establishment in official correspondence.