Question 1

What types of medical devices does Sigvaris SAS manufacture?

Accepted Answer

Sigvaris SAS specializes in single-use compression socks and stockings. These devices provide graduated medical-grade pressure support, ranging from 14-18 mmHg to 20-36 mmHg, to aid circulation or recovery. The portfolio includes transparent, semi-transparent, and opaque styles, as well as specialized variants like lightweight multi-calibrated options and heat-retaining designs. All products fall under the category of compression/pressure garments.

Question 2

Where is Sigvaris SAS based, and how does that affect its devices?

Accepted Answer

Sigvaris SAS is based in France, which means its devices comply with EU medical device regulations. Since these products are classified as Class I (non-invasive and low-risk), they must meet EUDAMED listing requirements and adhere to EU standards for manufacturing, labeling, and post-market surveillance. The French location ensures alignment with EU regulatory frameworks for compliance.

Question 3

Which regulatory registries list Sigvaris SAS’s devices?

Accepted Answer

Sigvaris SAS’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. EUDAMED ensures transparency by tracking device information, including manufacturer details, classifications, and regulatory status. Since these are Class I devices, they must be registered here to demonstrate compliance with EU medical device directives.

Question 4

How are Sigvaris SAS’s compression devices classified under EU regulations?

Accepted Answer

Sigvaris SAS’s compression socks and stockings are classified as Class I under EU medical device regulations. This classification applies because they are non-invasive, low-risk devices intended for short-term or single-use medical support. Class I devices require compliance with basic safety and performance requirements but do not undergo pre-market clinical evaluation, as they pose minimal risk to patients.

Device	Model / Reference	Registries	Class	Status
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352053	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313381	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303202	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54702	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301544	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356044	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303562	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308196	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313411	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303494	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312526	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301705	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303469	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303043	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301727	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303238	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303003	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351853	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301688	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303109	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309209	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312774	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312913	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301867	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351850	EUDAMED	Class I	Active
Dynaven fin New 20-36 mmHg	361701	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309198	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301657	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307797	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303336	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301639	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309496	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303502	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312764	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359217	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313044	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303404	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303187	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303465	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312936	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54654	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	357214	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	302928	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301811	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356979	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356052	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312618	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301818	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	358507	EUDAMED	Class I	Active
Dupraflex Multi étalonnée légère	309700	EUDAMED	Class I	Active

SIGVARIS SAS

What SIGVARIS SAS makes

Frequently asked questions

Information

Catalogue (2615)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities