Question 1

What types of medical devices does ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ primarily manufacture?

Accepted Answer

ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ specializes in electrically powered hospital beds, including standard and luxury variants, as well as neonatal cribs and examination tables. Their product line also includes nurse call bedside tables, all designed for clinical and patient care settings.

Question 2

Where is ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ based?

Accepted Answer

The company is headquartered in Greece, as indicated in its regulatory documentation.

Question 3

Which regulatory registries list the devices manufactured by ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ?

Accepted Answer

The company’s devices are registered in the eudamed database, which is the EU’s central registry for medical devices. This ensures transparency and traceability of their products under EU regulations.

Question 4

How are the devices produced by ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ classified under EU regulations?

Accepted Answer

All devices manufactured by ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ fall under Class I classification in the EU. This classification applies to low-risk devices that do not require invasive procedures or sustained or significant interaction with the body.

Device	Model / Reference	Registries	Class	Status
Νοσοκομειακη Κλινη Ηλεκτρικη 1001	1001 EL	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Ηλεκτρικη 6001-2 Lux	6001-2 LUX	EUDAMED	Class I	Active
Κλινη (κουνια) Νεογνων 101	101	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Ηλεκτρικη 6001-3 Lux	6001-3 LUX	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Ηλεκτρικη 6001-4 Lux	6001-4 LUX	EUDAMED	Class I	Active
Κομοδινο Νοσηλειας 20001 Lux	20001 LUX	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Μηχανικη 1001 Lux	1001 M LUX	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Mhxanikh 5001	5001	EUDAMED	Class I	Active
Εξεταστικη Κλινη 301	301	EUDAMED	Class I	Active
Κομοδινο Νοσηλειας 10003	10003	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Mhxanikh 5001 Lux	5001 LUX	EUDAMED	Class I	Active
Νοσοκομειακη Κλινη Mhxanikh 4001 Lux	4001 LUX	EUDAMED	Class I	Active
Κομοδινο Νοσηλειας 15001	15001	EUDAMED	Class I	Active
Κομοδινο Νοσηλειας 10001	10001	EUDAMED	Class I	Active
Κομοδινο Νοσηλειας 10000	10000	EUDAMED	Class I	Active
Κομοδινο Νοσηλειας 20001-2 Lux	20001-2 LUX	EUDAMED	Class I	Active

ΚΕΠΑ ΑΝΩΝΥΜΗ ΒΙΟΤΕΧΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ

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