Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013636348

FEI Number

3013636348

Entity Name

ZOLLNER ELECTRONICS COSTA RICA LIMITADA

City/State/Country

CARTAGO, CR

Establishment Address

Zollner Electronics Costa Rica Limitada, 100 O de Gas Zeta Zona Franca, La Lima Industrial Park, CARTAGO 30104, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zollner Electronics Costa Rica Limitada (Owner Number: 10091359)

Owner / Operator Contact Address

Zollner Electronics Costa Rica Limitada, 100 O de Gas Zeta Zona Franca, La Lima Industrial Park, CARTAGO, CR-C 30104, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

t:slim X2

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	2024-09-04

Official Correspondent

Hilda Chaves

US Agent Details

Azfar Jafri Business: ZOLLNER ELECTRONICS COSTA RICA LIMITADA Email: azfar.jafri@zollner-electronics.com Phone: (408) 4345433

Related Public Records

Same Entity

Zollner Electronics Costa Rica Limitada

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

View Entity Profile →

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

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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 3013636348. Last updated year: 2026. Please use registration number 3013636348 when referencing this establishment in official correspondence.