Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010017366

FEI Number

3010017366

Entity Name

MAQUET CARDIOPULMONARY MEDIKAL TEKNIK SAN. TIC.LTD. STI.

City/State/Country

Konyaalti Antalya, TR

Establishment Address

Antalya Serbest Bolgesi R ada Yeni Liman, Konyaalti Antalya 07070, TR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Maquet Cardiopulmonary Medikal Teknik San. Tic.Ltd. Sti. (Owner Number: 10042484)

Owner / Operator Contact Address

Antalya Serbest Bolgesi R ada Yeni Liman, Konyaalti, TR-07 07070, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Edi Catheter ENFit Arterial HLS-Cannula, 13 Fr., Non-Coated, With BIOLINE And With SOFTLINE Coating

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-01-09
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-01-09
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Maquet Cardiopulmonary Medikal Teknik San. Tic.Ltd. Sti.

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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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1921846	Cardinal Health	Hazelwood, MO, US
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010017366. Last updated year: 2026. Please use registration number 3010017366 when referencing this establishment in official correspondence.