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 Styles opaque 15-20 mmHg	301516	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307631	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301687	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301552	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303325	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301876	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307693	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303136	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359261	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312929	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301905	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303279	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	357051	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313139	EUDAMED	Class I	Active
Dynaven fin New 20-36 mmHg	361714	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313203	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308083	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303077	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312943	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301763	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356980	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307564	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359250	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303111	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313478	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301836	EUDAMED	Class I	Active
Sigvaris Active résistant 15-20 mmHg	307242	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356029	EUDAMED	Class I	Active
Dupraflex Multi étalonnée forte	309704	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316865	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303488	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351838	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303438	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308079	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356022	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307568	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309511	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320866	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356047	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303456	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359259	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313646	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320852	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301580	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X33500	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301603	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	357222	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313450	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309275	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	357122	EUDAMED	Class I	Active

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