Question 1

What types of medical devices does Tur-Med Hastane Malz. San. Tic. Ltd. Şti. primarily manufacture?

Accepted Answer

Tur-Med primarily manufactures basic electric hospital beds, including variations like single-motor, dual-motor, four-motor, and intensive care unit beds with five-column motors. Their portfolio also includes folding and hydraulic stretchers, motorised and wooden examination tables, and a home-type folding wheelchair with a commode attachment. Additionally, they produce a tissue specimen x-ray system, which is classified as an in vitro diagnostic (IVD) device.

Question 2

Where is Tur-Med Hastane Malz. San. Tic. Ltd. Şti. based, and how does that affect its regulatory compliance?

Accepted Answer

Tur-Med is based in Turkey, which means its devices must comply with EU regulations if marketed in the European Economic Area. Since all listed devices fall under EU Class I classification, they are subject to basic requirements under EU MDR (Medical Device Regulation). The company registers its devices in euDaMed, the EU’s public registry for medical devices, to demonstrate compliance and traceability.

Question 3

Which regulatory databases list Tur-Med’s medical devices, and why is this important?

Accepted Answer

Tur-Med’s devices are listed in euDaMed, the official EU database for medical devices. This registry is critical because it ensures transparency and traceability of devices marketed in the European Union. Listing in euDaMed confirms that the manufacturer has provided necessary information about their devices, including classification, intended purpose, and compliance with EU regulations, which helps healthcare professionals and authorities verify legitimacy.

Question 4

How are Tur-Med’s devices classified under EU regulations, and what does that mean for their use?

Accepted Answer

All of Tur-Med’s listed devices fall under EU Class I classification, which is the lowest risk category for medical devices. This classification means they pose minimal risk to patients and users, so they are subject to basic safety and performance requirements but do not require additional conformity assessments like clinical evaluations or third-party audits. However, even Class I devices must still comply with general safety principles and be properly labeled for their intended use.

Device	Model / Reference	Registries	Class	Status
Home-Type Folding Wheelchair with Commode	TM-H-8003	EUDAMED	Class I	Active
Stretcher(folding)	TM-C 3001	EUDAMED	Class I	Active
Patient Bed(dual Motor)	TM-D 4034	EUDAMED	Class I	Active
Examination Table(single Motor)	TM-A 1025	EUDAMED	Class I	Active
Intensive Care Unit Patient Bed Column Motor (five Motors)	TM-D 4080	EUDAMED	Class I	Active
Stretcher(hydraulic)	TM-C 3017	EUDAMED	Class I	Active
Examination Table(two Motor)	TM-A 1026	EUDAMED	Class I	Active
Pediatric Examination Table(wooden)	TM-K 2217	EUDAMED	Class I	Active
Patient Bed	TM-D 4001	EUDAMED	Class I	Active
Patient Bed(four Motor)	TM-D 4059	EUDAMED	Class I	Active
Emergency Stretcher	TM-C 3033	EUDAMED	Class I	Active
Tur-Med Hastane Malz. San. Ti̇c. Ltd. Şti̇.	TM-A 1021	EUDAMED	Class I	Active
Intensive Care Unit Patient Bed Column Motor (four Motors)	TM-D 4053	EUDAMED	Class I	Active
Gyneacological Examination Table	TM-A 1011	EUDAMED	Class I	Active
Anti Decubitus Mattress	TM-D 4078	EUDAMED	Class I	Active
Pediatric Patient Bed (single Motor)	TM-K 2213	EUDAMED	Class I	Active
Examination Table(folding)	TM-A 1001	EUDAMED	Class I	Active
Patient Bed(dual Motor)	TM-D 4025	EUDAMED	Class I	Active
Orthopedi̇c Traction Frame	TM-D 4036	EUDAMED	Class I	Active
Patient Bed(two Setting)	TM-D 4017	EUDAMED	Class I	Active
Examination Table(fixed)	TM-A 1002	EUDAMED	Class I	Active
Examination Lamp	TM-F 6013	EUDAMED	Class I	Active
Patient Bed(three Setting)	TM-D 4071	EUDAMED	Class I	Active
Pediatric Stretcher	TM-K 2215	EUDAMED	Class I	Active
Patient Bed(dual Motor)	TM-D 4026	EUDAMED	Class I	Active
Patient Bed (two Setting Manuel - W/Bedpan)	TM-D 4020	EUDAMED	Class I	Active
Patient Bed(four Motors)	TM-D 4056	EUDAMED	Class I	Active
Mayo Table	TM-B 2003	EUDAMED	Class I	Active
Negatoskop(single)	TM-F 6003	EUDAMED	Class I	Active
Negatoskop(triple)	TM-F 6005	EUDAMED	Class I	Active
Tur-Med Hastane Malz. San. Ti̇c. Ltd. Şti̇.	TM-D 4058	EUDAMED	Class I	Active
Stretcher(with Upper Platform)	TM-C 3002	EUDAMED	Class I	Active
Delivery Bed(four Motor)	TM-D-4065	EUDAMED	Class I	Active
Pediatric Patient Bed (two Motor)	TM-K 2219	EUDAMED	Class I	Active
Patient Bed(two Setting, Manual)	TM-D 4021	EUDAMED	Class I	Active
Blood Donor Chair(two Motor)	TM-A 1022	EUDAMED	Class I	Active
Pediatric Mattress	TM-K 2211	EUDAMED	Class I	Active
Gyneacological And Delivery Table	TM-A 1027	EUDAMED	Class I	Active
Massage Table	TM-A 1007	EUDAMED	Class I	Active
Eye Scale	TM-F 6007	EUDAMED	Class I	Active
Negatoskop(double)	TM-F 6004	EUDAMED	Class I	Active
Iv Stand	TM-F 6026	EUDAMED	Class I	Active
Patient Bed(three Setting)	TM-D 4070	EUDAMED	Class I	Active
Massage Table	TM-A 1006	EUDAMED	Class I	Active
Cnc Mattress	TM-D 4069	EUDAMED	Class I	Active
EXAMINATION TABLE(motor)	TM-A 1024	EUDAMED	Class I	Active
Patient Bed(dual Motor)	TM-D 4077	EUDAMED	Class I	Active
Gyneacological Examination Table	TM-A 1013	EUDAMED	Class I	Active
Infant Cot	TM-K 2210	EUDAMED	Class I	Active
Patient Bed(three Motor)	TM-D 4055	EUDAMED	Class I	Active

TUR-MED HASTANE MALZ. SAN. TIC. LTD. ŞTI.

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