Data / Medical devices / China / Linhai Deyi Plastic Co., Ltd

Linhai Deyi Plastic Co., Ltd: FDA-registered device maker in Linhai City Zhejiang, China, 2 510(k) clearances

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

Linhai Deyi Plastic Co., Ltd is registered with the FDA (registration 3004941127) in Linhai City Zhejiang, China. It lists 15 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 16, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004941127
Address: No. 17-1, Binhai First Avenue Shangpan Town, Linhai City Zhejiang, China, 317015
Owner or operator: LINHAI DEYI PLASTIC CO., LTD (9069276)
Roles: Contract manufacturer, Manufacturer
First device listed: April 10, 2006
Registered through: 2026
Brand names listed: AMSmooth, Amsino, CLAMP, CONTAINER LIQUID MEDICATION GRADUATED, CONTAINER SPECIMEN MAILER ANDSTORAGE STERILE, CONTAINER SPECIMEN NON-STERILE, CONTAINER SPECIMEN STERILE, CULTRUE DISH and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Scrub, Operating-Room	GEC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dish, Tissue Culture	KIZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer, 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
February 16, 2010	K092870	NON-STERILE DISPOSABLE VAGINAL SPECULUM	HIB	Substantially Equivalent	Kunshan Deyi Plastic Co., Ltd.	accessdata.fda.gov
May 11, 1995	K951528	AMSINO DISPOSABLE VIGINAL SPECULUM	HIB	Substantially Equivalent	Amsino Intl., Inc.	accessdata.fda.gov

Compare with other makers

Updated February 16, 2010. 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.