Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015218509

FEI Number

3015218509

Entity Name

CeQur SA

City/State/Country

Horw Luzern, CH

Establishment Address

Ebenaustrasse 10, Horw Luzern 6048, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CeQur Corporation (Owner Number: 10046968)

Owner / Operator Contact Address

355 SOUTH MAIN STREET, Greenville, SC 29601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163357

PMA Number

N/A

All Registered Proprietary Names

CeQur Simplicity Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2019-02-04
OPP	Pump, Infusion, Insulin Bolus	General Hospital	Class 2	880.5725	2019-02-04

Official Correspondent

Michael Simpson

US Agent Details

Michael Simpson Business: CEQUR CORPORATION Email: mike.simpson@cequr.com Phone: (404) 2765449

Related Public Records

Same Entity

CeQur Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007871880	CeQur Corporation	Greenville, SC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082590	Lifescan, Inc.	SYMPHONY METER REMOTE	2008-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712
Z-0011-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 512

Similar Registrations

Registration Number	Establishment Name	Location
3007871880	CeQur Corporation	Greenville, SC, US
3013636348	ZOLLNER ELECTRONICS COSTA RICA LIMITADA	CARTAGO, CR
2029275	Sterigenics U.S., LLC	Corona, CA, US
3012307300	ICU Medical, Inc.	Minneapolis, MN, US
3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015218509. Last updated year: 2026. Please use registration number 3015218509 when referencing this establishment in official correspondence.