Data / Medical devices / China / Jianerkang Medical Co., Ltd.

Jianerkang Medical Co., Ltd.: FDA-registered device maker in Changzhou City Jiangsu, China, 2 510(k) clearances

Name: Jianerkang Medical Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jianerkang Medical Co., Ltd. is registered with the FDA (registration 9616874) in Changzhou City Jiangsu, China. It lists 18 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Jianerkang Medical Co., Ltd.

FDA registration number: 9616874
FEI number: 3006403682
Address: No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District, Changzhou City Jiangsu, China, 213251
Owner or operator: JIANERKANG MEDICAL CO., LTD. (9041776)
Roles: Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
First device listed: June 13, 2000
Registered through: 2027
Brand names listed: Absorbent Gauze Roll 100% cotton; Burn Pad; Cotton Ball; Dental Roll 100% cotton; Dressing Pack for Heavy Drainage;, Absorbent Patient Underpad, Anti fog solution and accessories, endoscopy, AquaPak Humidifier Adapters; Aquapak Sterile Humidifier Reservoirs; AquaPak Bubble Prefilled Humidif, Aquapak Prefilled Humidifier, Bandage, liquid, skin protectant, CONTAINER, SPECIMEN, NON-STERILE, Connecting tube and more

Devices it lists

Device	Product code	Class	Role	Source
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Contract manufacturer	accessdata.fda.gov
Bandage, Cast	ITG	1	Contract manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal	EFQ	U	Contract manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Contract manufacturer	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Media, Coupling, Ultrasound	MUI	2	Manufacturer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Contract manufacturer, Contract sterilizer, Exporter to the US	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
December 15, 2023	K232957	Sterile and Non-Sterile Ultrasound Gels	MUI	Substantially Equivalent	Jianerkang Medical Co., Ltd.	accessdata.fda.gov
April 10, 2012	K112110	STERILE LUBRICATING JELLY	KMJ	Substantially Equivalent	Jianerkang Medical Dressing Company	accessdata.fda.gov

Compare with other makers

Updated December 15, 2023. 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.