Question 1

What types of medical devices does Inverdia AB manufacture?

Accepted Answer

Inverdia AB specialises in compression therapy products, specifically graduated compression stockings and sleeves. Examples include the Venoline 140 den and Venoline FAS, which are designed to improve blood flow in the veins and alleviate symptoms of chronic venous insufficiency. These devices fall under the category of Class I medical devices.

Question 2

Where is Inverdia AB based?

Accepted Answer

Inverdia AB is headquartered in Sweden. The company’s location in Sweden aligns with EU regulatory frameworks, which govern the classification and compliance of its medical devices.

Question 3

Which regulatory registries list Inverdia AB’s devices?

Accepted Answer

Inverdia AB’s medical devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of devices authorised under EU regulations.

Question 4

How are Inverdia AB’s devices classified under EU regulations?

Accepted Answer

Inverdia AB’s devices, such as the Venoline series, are classified as Class I medical devices. This classification applies because compression therapy products like these pose minimal risk to patients and typically do not require invasive procedures, aligning with EU criteria for lower-risk devices.

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Device	Model / Reference	Registries	Class	Status
Venoline 140 den	VN434XSNU	EUDAMED	Class I	Active
Venoline 140 den	VN432XSBL	EUDAMED	Class I	Active
Venoline 140 den	VN434XLNU	EUDAMED	Class I	Active
Venoline 140 den	VN433SNU	EUDAMED	Class I	Active
Venoline 140 den	VN432MSA	EUDAMED	Class I	Active
Venoline 140 den	VN432XLSA	EUDAMED	Class I	Active
Venoline FAS	VN702XRR	EUDAMED	Class I	Active
Venoline FAS	VN702MSR	EUDAMED	Class I	Active
Venoline FAS	VN702SSR	EUDAMED	Class I	Active
Venoline FAS	VN700GMR	EUDAMED	Class I	Active
Venoline FAS	VN700GMS	EUDAMED	Class I	Active
Venoline FAS	VN702MLL	EUDAMED	Class I	Active
Venoline FAS	VN700GSR	EUDAMED	Class I	Active
Venoline FAS	VN700GSS	EUDAMED	Class I	Active
Venoline FAS	VN701DXR	EUDAMED	Class I	Active
Venoline FAS	VN702MSL	EUDAMED	Class I	Active
Venoline FAS	VN702XLR	EUDAMED	Class I	Active
Venoline 140 den	VN432XLBL	EUDAMED	Class I	Active
Venoline FAS	VN702SSL	EUDAMED	Class I	Active
Venoline FAS	VN701DXS	EUDAMED	Class I	Active
Venoline 140 den	VN432SSA	EUDAMED	Class I	Active
Venoline FAS	VN701DLS	EUDAMED	Class I	Active
Venoline FAS	VN701DXL	EUDAMED	Class I	Active
Venoline FAS	VN702XSR	EUDAMED	Class I	Active
Venoline On	VN7010	EUDAMED	Class I	Active
Venoline FAS	VN702MRL	EUDAMED	Class I	Active
Venoline FAS	VN702XSL	EUDAMED	Class I	Active
Venoline FAS	VN700GSL	EUDAMED	Class I	Active
Venoline FAS	VN701DMS	EUDAMED	Class I	Active
Venoline FAS	VN701DSR	EUDAMED	Class I	Active
Venoline On	VN7012	EUDAMED	Class I	Active
Venoline 140 den	VN432MBL	EUDAMED	Class I	Active
Venoline FAS	VN700GLS	EUDAMED	Class I	Active
Venoline FAS	VN700GLL	EUDAMED	Class I	Active
Venoline FAS	VN702SLL	EUDAMED	Class I	Active
Venoline 140 den	VN432SNU	EUDAMED	Class I	Active
Venoline FAS	VN701DSL	EUDAMED	Class I	Active