Data / Medical devices / Mexico / Bemis De Mexico, S.A. DE C.V.

Bemis De Mexico, S.A. DE C.V.: FDA-registered device maker in Cienega De Flores Nuevo Leon, Mexico, 6 510(k) clearances

Name: Bemis De Mexico, S.A. DE C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bemis De Mexico, S.A. DE C.V. is registered with the FDA (registration 3011198121) in Cienega De Flores Nuevo Leon, Mexico. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 14, 1997. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011198121
Address: AV TEXAS 200 Parque Industrial Nacional, Cienega De Flores Nuevo Leon, Mexico, 65550
Owner or operator: BEMIS MANUFACTURING COMPANY (9008164)
Roles: Manufacturer
First device listed: February 15, 2008
Registered through: 2026
Brand names listed: 1000cc Quick Fit Suction Liner, 1500cc Quick Fit Suction Liner, 3000cc Quick Fit Suction Liner, BEMIS TWO GALLON SHARPS CONTAINER, Bemis One Quart Phlebotomy Container, Bemis SharpSentinal, Bemis Two Gallon Chemotherapy, Chemotherapy Container and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Container, Sharps	MMK	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	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 14, 1997	K965248	BEMIS TWO GALLON SHARPS CONTAINER	FMI	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
February 11, 1997	K964858	BEMIS TWO GALLON CHEMOTHERAPY CONTAINER	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
March 28, 1996	K960525	BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
November 27, 1995	K953797	SHARPS DISPOSAL CONTAINERS	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
June 2, 1995	K950340	IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
December 20, 1977	K771737	SUCTION CANISTER	GCX	Substantially Equivalent	Bemis Health Care	accessdata.fda.gov

Compare with other makers

Updated February 14, 1997. 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.