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Jiangsu Shenli Medical Production Co.,ltd: FDA-registered device maker in CHANGZHOU Jiangsu, China, 1 510(k) clearance

Name: Jiangsu Shenli Medical Production Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jiangsu Shenli Medical Production Co.,ltd is registered with the FDA (registration 3003902757) in CHANGZHOU Jiangsu, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 14, 2017. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003902757
Address: No 20, Changzheng Road ZHENGLU, CHANGZHOU Jiangsu, China, 213111
Owner or operator: Jiangsu Shenli Medical Production Co., Ltd (9053084)
Roles: Contract manufacturer, Manufacturer
First device listed: May 25, 2007
Registered through: 2027
Brand names listed: CATHETER, IMC IRRIGATION SET, MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET, Safety Blood Collection Set

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Contract manufacturer	accessdata.fda.gov
Catheter, Continuous Irrigation	GBQ	1	Contract manufacturer	accessdata.fda.gov
Ear Irrigation Kit	OGQ	1	Contract manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 14, 2017	K163093	Safety Blood Collection Set	FMI	Substantially Equivalent	Jiangsu Shenli Medical Production Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 5, 2024	94520	Class II	Ongoing	Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No	Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).	accessdata.fda.gov

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Updated May 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.