Data / Medical devices / China / Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd.

Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances

Name: Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. is registered with the FDA (registration 3008729549) in Shanghai, China. It lists 25 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008729549
Address: 17 Floor, No. 757 Guangfu Rd., Shanghai, China, 200070
Owner or operator: Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. (10034056)
Roles: Exporter to the US
First device listed: January 6, 2011
Registered through: 2026
Brand names listed: Chair, Adjustable, Mechanical, Container, Specimen Mailer And Storage, Non-Sterile, Coverslips, Microscope Slide, DISPOSABLE MOUTH MIRROR, Needle, Hypodermic, Single Lumen, PLASTIC MASSAGE TOOL, Pad, Heating, Powered, STEP DOWN TIP and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Adaptor, Holder, Syringe	IQG	1	Exporter to the US	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Exporter to the US	accessdata.fda.gov
Bag, Ice	KYR	1	Exporter to the US	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Exporter to the US	accessdata.fda.gov
Collector, Urine, Pediatric, For Indwelling Catheter	FFH	2	Exporter to the US	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Exporter to the US	accessdata.fda.gov
Coverslips, Microscope Slide	KES	1	Exporter to the US	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Exporter to the US	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Exporter to the US	accessdata.fda.gov
Mirror, Mouth	EAX	1	Exporter to the US	accessdata.fda.gov
Needle, Dental	DZM	1	Exporter to the US	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Exporter to the US	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Exporter to the US	accessdata.fda.gov
Scraper, Tongue	LCN	1	Exporter to the US	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Exporter to the US	accessdata.fda.gov
Table, Mechanical	INW	1	Exporter to the US	accessdata.fda.gov
Table, Powered	INQ	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Exporter to the US	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Exporter to the US	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	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 19, 2019	K191643	TK Sterile Hypodermic Needle	FMI	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
April 14, 2011	K101468	3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE	FYA	Substantially Equivalent	3M Company Corp	accessdata.fda.gov

Compare with other makers

Updated December 19, 2019. 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.