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OKUMAN MEDIKAL SISTEMLER ANONIM SIRKETI

Türkiye·TR-MF-000015167

Last updated September 18, 2026

About

OKUMAN Medikal Sistemler In 2010, Ankara started its commercial life in sleep and respiratory disorders. With its continuously developing, trained and experienced sales, marketing, clinical support and technical service staff, our country’s fastest growing and most sleeping center has become home-care company. In addition to the home care products, surgery is located among the largest companies of OKUMAN Turkey on Intensive Care, Cardiology, Newborn, Sleep Diagnosis and Treatment Devices. OKUMAN has carried out the first design and production of many medical devices in our country, mainly for anesthesia devices, baby nurseries and phototherapy devices. We manufacture ISO 9001, ISO 13485, CE and Domestic Manufacturing Certificates in the Ivedik Organized Industrial Zone. OKUMAN is distributor of the PMLS product group with its own products, NDD, MEC, Enmind firms. OKUMAN has signed many hospital projects at home and abroad with CE and TSE quality certified products, completed the hospital installation of products with success, after-sales, technical service services. OKUMAN MEDICAL SYSTEMS, the world leader in its field and the distributor of the most reputable brands, brings its products with consumers at home and abroad.

Translated from the manufacturer's own website. Source

What OKUMAN MEDIKAL SISTEMLER ANONIM SIRKETI makes

The company manufactures medical devices for critical care, including phototherapy systems designed for intensive care units, defibrillator monitors, ventilators, infant incubators, and central monitoring systems. Additional products include multi-parameter patient monitors, which track vital signs such as heart rate, blood pressure, and oxygen levels in real-time for hospitalised patients.

These devices fall under Class IIb classification under EU regulations and are listed in the EUDAMED database. The company operates from Turkey and adheres to ISO 9001 and ISO 13485 standards, alongside CE marking requirements for market authorisation.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does OKUMAN Medikal Sistemler Anonim Şirketi manufacture?

OKUMAN Medikal Sistemler Anonim Şirketi specializes in critical care medical devices. Its portfolio includes phototherapy systems for intensive care units, defibrillator monitors, ventilators, infant incubators, central monitoring systems, and multi-parameter patient monitors. These devices are designed to support life-saving functions in hospital settings, such as real-time vital sign monitoring, respiratory assistance, and neonatal care.

Where is OKUMAN Medikal Sistemler Anonim Şirketi based?

The company is based in Turkey, specifically operating from Ankara. It manufactures its devices in the Ivedik Organized Industrial Zone, adhering to local and international quality standards.

Are OKUMAN’s medical devices listed in any regulatory registries?

Yes, OKUMAN’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing is required for devices that have undergone the necessary conformity assessment procedures, such as CE marking, to demonstrate compliance with EU regulations.

How are OKUMAN’s medical devices classified under EU regulations?

OKUMAN’s medical devices fall under Class IIb classification according to EU regulations. This classification applies to devices that pose a moderate to high risk to patients, such as those used in critical care, monitoring, and life-support functions. Class IIb devices require rigorous conformity assessment, including clinical evaluations and quality management system certifications like ISO 13485, to ensure safety and performance before market authorization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Türkiye
Address: Alci Osb Mah. 2011 Cad., Bina No: 12 Sincan/ Ankara, Ankara, Türkiye
Website: www.okuman.com.tr
LinkedIn: linkedin.com/company/okuman-medikal-sistemler-ltd.-%C5%9Fti.
Facebook: —
Email: [email protected]
Phone: +90 312 384 05 20
PRRC Contact: PERİHAN GÜLEÇ
EUDAMED SRN: TR-MF-000015167
FDA FEI Number: —
DUNS Number: —

Catalogue (61)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Intensive Care Phototherapy	BC 050 000	EUDAMED	Class IIb	Active
Intensive Care Phototherapy	BC 050 000	EUDAMED	Class IIb	Active
Intensive Care Phototherapy	BC 050 000	EUDAMED	Class IIb	Active
Defibrillator Monitor	DFM 600	EUDAMED	Class IIb	Active
Ventilator Device	OKM IBS	EUDAMED	Class IIb	Active
Infant Incubator	OKM 862 000	EUDAMED	Class IIb	Active
Central Monitoring System	OKM 8800	EUDAMED	Class IIb	Active
Infant Incubator	OKM 801 777	EUDAMED	Class IIb	Active
Infant Incubator	OKM 862 444	EUDAMED	Class IIb	Active
Infant Incubator	OKM 801 333	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 104 000	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM VS3 000	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 Gelişmiş	EUDAMED	Class IIb	Active
Intensive Care Phototherapy	BC 050 000	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 84	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 300 000	EUDAMED	Class IIb	Active
Transport Incubator	TR 203 025	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 555	EUDAMED	Class IIb	Active
Infant Incubator	OKM 862 777	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 LCD	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 500 030	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 500 025	EUDAMED	Class IIb	Active
Infant Incubator	OKM 801 000	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 ECO	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 860	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 500 050	EUDAMED	Class IIb	Active
Intensive Care Phototherapy	BC 250 000	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 500 010	EUDAMED	Class IIb	Active
Ventilator Device	OKM IBS	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 STANDART	EUDAMED	Class IIb	Active
Central Monitoring System	OKM 8800	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 800	EUDAMED	Class IIb	Active
Resuscitation Device	OKM 150	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 500 005	EUDAMED	Class IIb	Active
Infant Incubator	OKM 862 888	EUDAMED	Class IIb	Active
Infant Incubator	OKM 801 111	EUDAMED	Class IIb	Active
Infant Incubator	OKM 862 222	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 DUVARA MONTE	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730 FULL	EUDAMED	Class IIb	Active
Defibrillator Monitor	DFM 800	EUDAMED	Class IIb	Active
Defibrillator Monitor	DFM 800	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OKM 500 060	EUDAMED	Class IIb	Active
Intensive Care Phototherapy	BC 050 000	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730-222	EUDAMED	Class IIb	Active
Radiant Warmer	OKM 730	EUDAMED	Class IIb	Active
Infant Incubator	OKM 862 666	EUDAMED	Class IIb	Active
Infant Incubator	OKM 801 666	EUDAMED	Class IIb	Active
Defibrillator Monitor	DFM 600	EUDAMED	Class IIb	Active

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