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 Essentiel semi-transparent 15-20 mmHg	312843	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313365	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312857	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356028	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301837	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301473	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320850	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301722	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301788	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312285	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313517	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301706	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313308	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312882	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313099	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312721	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303039	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303092	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316876	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313407	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303222	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313296	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312716	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309450	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303495	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301479	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	361935	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312600	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301764	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313417	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54718	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301879	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	313264	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313147	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303454	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301581	EUDAMED	Class I	Active
Sigvaris ATH	309424	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307781	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301915	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312726	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307598	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308204	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309589	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309276	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309204	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301551	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303017	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313521	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312781	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312944	EUDAMED	Class I	Active

SIGVARIS SAS

What SIGVARIS SAS makes

Frequently asked questions

Information

Catalogue (2615)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities