Question 1

What types of medical devices does Arşimed Medical Kozmetik Bilim İhtisas İhracat Pazarlama Ticaret Limited Şti. primarily manufacture?

Accepted Answer

Arşimed Medical primarily manufactures basic electric hospital beds, specifically designed for use in hospital and healthcare environments. These devices are intended to provide patient care with features like adjustable positioning, ensuring comfort and accessibility for medical staff and patients.

Question 2

Where is Arşimed Medical based, and what region does it serve?

Accepted Answer

Arşimed Medical is based in Turkey. While the company’s primary focus is on manufacturing medical devices for domestic and regional markets, its products are designed to meet international standards, including EU regulations, which may facilitate use in other countries where applicable.

Question 3

How are Arşimed Medical’s devices classified under EU regulations?

Accepted Answer

Arşimed Medical’s devices, including the ARCHIMED model, are classified as Class I under EU medical device regulations. This classification applies to low-risk devices that pose minimal risk to patients and users, such as basic electric hospital beds, which typically require less stringent regulatory oversight compared to higher-risk categories.

Question 4

Are Arşimed Medical’s devices listed in any regulatory databases?

Accepted Answer

Yes, Arşimed Medical’s devices are listed in the eudamed database. This EU-wide registry is used to track medical devices that have been placed on the market in compliance with EU regulations, ensuring transparency and traceability for healthcare professionals and authorities.

Device	Model / Reference	Registries	Class	Status
Archimed	BT32-E TINYSIT MINI BLOOD DONATION CHAIR	EUDAMED	Class I	Active
Archimed	ST04-PS PROCTOLOGY AND ENDOSCOPY ANORECTAL TABLE	EUDAMED	Class I	Active
Moment Surgical Chair	ST04-S	EUDAMED	Class I	Active
Archimed	ES20-G S-STONE BARIATRIC EMERGENCY STRETCHER	EUDAMED	Class I	Active
Archimed	DC24-A CAPSULE PEDIATRIC DIALYSIS AND CHEMOTHERAPY CHAIR 4 MOTORS	EUDAMED	Class I	Active
Archimed	PB02-G UNIQUE 2 MOTORS HOSPITAL BED	EUDAMED	Class I	Active
Archimed	BT04-E AVANGARDE BLOOD DONATION CHAIR	EUDAMED	Class I	Active
Archimed	CB03-M WIGGLE CHILD BED, 3 MOTORS	EUDAMED	Class I	Active
Archimed	ST04-PM PROCTOLOGY AND ENDOSCOPY ANORECTAL TABLE	EUDAMED	Class I	Active
Archimed	PB03-A UNIQUE MINUS 3 MOTORS HOSPITAL BED	EUDAMED	Class I	Active
Archimed	BT12-M MICRA BLOOD DONATION CHAIR	EUDAMED	Class I	Active
Archimed	DC14-S DIASIT DILAYSIS AND CHEMOTHERAPY CHAIR 4 MOTORS	EUDAMED	Class I	Active
Archimed	EN14-M ALPHA ENT CHAIR 4 MOTORS	EUDAMED	Class I	Active
Archimed	PB02-TE UNIQUE 2 MOTORS HOSPITAL BED WITH TRENDELENBURG	EUDAMED	Class I	Active
Archimed	PB04-BG UNIQUE PLUS HOSPITAL BED 4 MOTORS	EUDAMED	Class I	Active
Manual Hospital Bed One Movement With Aluminium Side Rails	MB01-S	EUDAMED	Class I	Active
Archimed	DT00-M VERSA OVERBED TABLE	EUDAMED	Class I	Active
Archimed	BT32-S TINYSIT MINI BLOOD DONATION CHAIR	EUDAMED	Class I	Active
Archimed	MB02-G MANUAL HOSPITAL BED TWO ADJUSTMENTS	EUDAMED	Class I	Active
Archimed	ES00-S SIGMA EMERGENCY STRETCHER	EUDAMED	Class I	Active
Archimed	PB25-S SENTINEL HOSPITAL BED	EUDAMED	Class I	Active
Archimed	PB24-M SENTINEL HOSPITAL BED	EUDAMED	Class I	Active
Archimed	DC24-S CAPSULE PEDIATRIC DIALYSIS AND CHEMOTHERAPY CHAIR 4 MOTORS	EUDAMED	Class I	Active
Archimed	CB02-A WIGGLE CHILD BED, 2 MOTORS	EUDAMED	Class I	Active
Archimed	PC03-S PODIATRY CHAIR 3 MOTORS	EUDAMED	Class I	Active
Archimed	PB14-S UNIQUE X CROSS ICU HOSPITAL BED	EUDAMED	Class I	Active
Archimed	OT03-M BETA GYNAECOLOGICAL TABLE	EUDAMED	Class I	Active
Archimed	EN14-E ALPHA ENT CHAIR 4 MOTORS	EUDAMED	Class I	Active
Archimed	MB02-PE MANUAL HOSPITAL BED TWO ADJUSTMENTS WITH PLASTIC SIDE RAIL	EUDAMED	Class I	Active
Archimed	BT24-E COMFYSIT BLOOD DONATION CHAIR	EUDAMED	Class I	Active

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