Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011198121

FEI Number

3011198121

Entity Name

Bemis De Mexico, S.A. DE C.V.

City/State/Country

Cienega De Flores Nuevo Leon, MX

Establishment Address

AV TEXAS 200 Parque Industrial Nacional, Cienega De Flores Nuevo Leon 65550, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BEMIS MANUFACTURING COMPANY (Owner Number: 9008164)

Owner / Operator Contact Address

300 MILL STREET, Sheboygan Falls, WI 53085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K953797

PMA Number

N/A

All Registered Proprietary Names

3000cc Quick Fit Suction Liner 1500cc Quick Fit Suction Liner 1000cc Quick Fit Suction Liner BEMIS TWO GALLON SHARPS CONTAINER Chemotherapy Container Eight and Eleven Gallon Sharps and Bemis One Quart Phlebotomy Container Bemis SharpSentinal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2008-02-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-05-29
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2009-04-06
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2009-01-29
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2009-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

Rebecca Foytik Business: BEMIS MANUFACTURING COMPANY Email: Karla.Quadracci@bemismfg.com Phone: (920) 4675325

Related Public Records

Same Entity

BEMIS MANUFACTURING COMPANY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2133713	BEMIS MANUFACTURING CO.	Sheboygan Falls, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011198121. Last updated year: 2026. Please use registration number 3011198121 when referencing this establishment in official correspondence.