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 ATH	309426	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313360	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313043	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309263	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301659	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308089	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359275	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303183	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309158	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351848	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302947	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359253	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303543	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301621	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313292	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301901	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303061	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309140	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312614	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303503	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314958	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309881	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303566	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359242	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313635	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	88703	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302943	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312546	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303159	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313337	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313386	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309160	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	97541	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309216	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309449	EUDAMED	Class I	Active
Sigvaris Active résistant 15-20 mmHg	307251	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309181	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312799	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312558	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301702	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312275	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	309118	EUDAMED	Class I	Active
Sigvaris ATH	309432	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352050	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54675	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302949	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307618	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313495	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301685	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312904	EUDAMED	Class I	Active

SIGVARIS SAS

What SIGVARIS SAS makes

Frequently asked questions

Information

Catalogue (2615)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities