Question 1

What types of medical devices does UZUMCU Medical Equipment and Gas Systems manufacture?

Accepted Answer

UZUMCU Medical Equipment and Gas Systems specializes in medical gas distribution systems, including central supply units, pipeline networks, and control valves for healthcare facilities. Their portfolio also covers medical oxygen concentrators, compressed gas cylinders for clinical use (such as oxygen, nitrogen, and medical air), and gas monitoring/alarm systems. These devices are designed to ensure reliable gas delivery and safety in patient care environments.

Question 2

Where is UZUMCU Medical Equipment and Gas Systems based?

Accepted Answer

The company is headquartered in Turkey, where it operates under national and EU regulatory frameworks. This location influences its compliance with both Turkish medical device regulations and EU requirements, particularly for devices marketed within the European Union.

Question 3

Which regulatory registries list UZUMCU’s medical devices?

Accepted Answer

UZUMCU’s devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. This platform ensures transparency and traceability of devices authorized under EU Medical Device Regulations (MDR).

Question 4

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

Accepted Answer

UZUMCU’s devices fall into Class I, Class IIa, and Class IIb categories under the EU Medical Device Regulations. Classification depends on factors like risk level, intended use, and potential harm to patients. For example, gas monitoring systems or control valves may require higher classification due to safety-critical functions, while simpler components (e.g., certain cylinders) might qualify as Class I.

Device	Model / Reference	Registries	Class	Status
Uzumcu	956281203	EUDAMED	Class IIb	Active
Uzumcu	30405	EUDAMED	Class IIa	Active
Uzumcu	MOS-20	EUDAMED	Class IIb	Active
Uzumcu	1603.10	EUDAMED	Class IIb	Active
Uzumcu	1603.05	EUDAMED	Class IIb	Active
Uzumcu	MOS-20	EUDAMED	Class IIb	Active
Uzumcu	1245.15	EUDAMED	Class IIb	Active
Uzumcu	66.1030	EUDAMED	Class IIb	Active
Uzumcu	30403	EUDAMED	Class IIa	Active
Uzumcu	1003.50	EUDAMED	Class IIb	Active
Uzumcu	1242.15	EUDAMED	Class IIa	Active
Uzumcu	1008.51	EUDAMED	Class IIb	Active
Uzumcu	67.1143	EUDAMED	Class IIa	Active
Uzumcu	66.1301	EUDAMED	Class IIb	Active
Uzumcu	1604.05	EUDAMED	Class IIb	Active
Uzumcu	1002.58	EUDAMED	Class IIb	Active
Uzumcu	66.1009	EUDAMED	Class IIb	Active
Uzumcu	1402.15R	EUDAMED	Class IIb	Active
Uzumcu	956281503	EUDAMED	Class IIb	Active
Uzumcu	66.1031	EUDAMED	Class IIb	Active
Uzumcu	MAS-6	EUDAMED	Class IIb	Active
Uzumcu	66,1043	EUDAMED	Class IIb	Active
Uzumcu	66.1045	EUDAMED	Class IIb	Active
Uzumcu	66.1390	EUDAMED	Class IIb	Active
Uzumcu	1402.15	EUDAMED	Class IIb	Active
Cryotheraphy Device	44.1049	EUDAMED	Class IIb	Active
Uzumcu	956281202	EUDAMED	Class IIb	Active
Uzumcu	VYD-103	EUDAMED	Class IIb	Active
Uzumcu	956280904	EUDAMED	Class IIb	Active
Uzumcu	1520.00B	EUDAMED	Class IIb	Active
Uzumcu	67.1205	EUDAMED	Class IIb	Active
Uzumcu	Senseo	EUDAMED	Class IIa	Active
Uzumcu	66.1151	EUDAMED	Class IIb	Active
Uzumcu	1422.05	EUDAMED	Class IIb	Active
Uzumcu	UZUMCU	EUDAMED	Class IIb	Active
Uzumcu	1001.05	EUDAMED	Class IIb	Active
Uzumcu	1030.10	EUDAMED	Class IIb	Active
Uzumcu	66.1521	EUDAMED	Class IIb	Active

UZUMCU MEDICAL EQUIPMENT and GAS SYSTEMS

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