Is Shanghai Kindly Enterprise Development Group Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Shanghai Kindly Enterprise Development Group Co., Ltd. → Supplier → Allomedo

Q: What does Shanghai Kindly Enterprise Development Group Co., Ltd. manufacture?

Registered with the FDA for 11 device types.

Shanghai Kindly Enterprise Development Group Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Ophthalmic Syringe and 9 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.

11device types registered with the FDA

3products catalogued under its own name

2510(k) clearances

Registration

FDA registration record for Shanghai Kindly Enterprise Development Group Co., Ltd.
Registered name	SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
Status	Registered
Registration expires	2026
Registration number	3005405146
FEI number	3005405146
DUNS	530462431
Establishment type	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Shanghai Kindly Enterprise Development Group Co., Ltd.
Chinese legal name	上海康德莱企业发展集团股份有限公司
Source	EMIS company database

Location

Address of Shanghai Kindly Enterprise Development Group Co., Ltd.
City	Jiading
Province	Shanghai
Address	NO. 658 GAOCHAO ROAD
Postal code	201803
Country	China

What It Makes

Device types Shanghai Kindly Enterprise Development Group Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Cannula, Surgical, General & Plastic Surgery	Class 1	SoftFil® EasyGuide; SoftFil® Precision	2022	14
Dispenser, Liquid Medication	Class 1	Oral Caretip Sterile Syringe, Irrigation flat top syringe, Oral Dispensing Syringe, SOL-M Oral Dispensing Syringe, Oral Syringe, Oral Dispenser and 5 more	2013	86
Low Dead Space Piston Syringe	Class 2	Syringe (Low Dead Space) with Safety Needle, VitreJect® Ophthalmic Syringes, VitreJect® Syringe	2025	5
Needle, Aspiration And Injection, Disposable	Class 1	Blunt Tip Aspirating Neelde	2015	37
Needle, Hypodermic, Single Lumen	Class 2	Sterile Insuin Syringe, Sterile Hypodermic Syringe for Single use with/without Ndl,, Disposable Syringe without needle, Insulin Syringe, Hypodermic needles, Sterile Hypodermic Needle for Single use and 2 more	2012	71
Ophthalmic Syringe	Class 2	VitreJect® Ophthalmic Syringes, VitreJect® Syringe	2026	3
Set, Administration, Intravascular	Class 2	Exel I.V. Administration SET, Exel Injection Plug with Cap, Exel I.V. Extension Set	2005	49
Syringe, Antistick	Class 2	Sol-Care 0.5ml Retractable Safety Syringes with Fixed Needle, Insulin Safety Syringe, Sol-Guard TB Safety Syringe, Sol-Guard Insulin Safety Syringe, DropSafe Insulin Safety Syringe, Syringe with Safety Needle and 1 more	2013	39
Syringe, Piston	Class 2	Sterile Syringes for Single Use, Sterile Insuin Syringe, Sterile Hypodermic Syringe for Single use with/without Ndl,, Disposable Syringe without needle, Insulin Syringe, Hypodermic needles and 7 more	2005	60
Syringe, Restorative And Impression Material	Class 1	EXEL 1ml Delivery Syringe	2024	49
System, Blood Collection, Vacuum-Assisted, Manual	Class 1	Blood Collection Device, Blood Collection Tube Holder	2012	31

Own-Brand Listings

Devices catalogued by Shanghai Kindly Enterprise Development Group Co., Ltd.
Product	Code	Catalogue numbers
Terumo	FMI	10
Terumo	MEG	8
Terumo	FMF	1

Clearances

2 clearances name Shanghai Kindly Enterprise Development Group 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 Shanghai Kindly Enterprise Development Group Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K223327	2023-02-16	FMI	Traditional	This company
K223678	2023-02-09	FMF	Traditional	This company
K233037	2023-12-12	FMI	Traditional	Zhejiang Kindly Medical Device Co., Ltd.
K112057	2011-12-14	FMF	Traditional	Shanghai Kindly Enterprise Dev. Group Co.,

From the Company

Published by the company on its own website, not by the FDA.

Information published by Shanghai Kindly Enterprise Development Group Co., Ltd.
Founded	1987
Employees	5,000
Factory area	21,000 square meters
Main products	medical puncture devices, syringes, needles, IV infusion equipment, drug delivery devices
Certifications	ISO 9001, ISO 13485, CE, FDA
Export markets	50+ countries
OEM and ODM	Offered

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer	Device types
Johnson Health Tech (Shanghai) Co., Ltd.	3

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.

Shanghai Kindly Enterprise Development Group Co., Ltd.