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 transparent 15-20 mmHg	301852	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308267	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307231	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312788	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303549	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303100	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301880	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313621	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313302	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309865	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303487	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309879	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312793	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303342	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359220	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301782	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303624	EUDAMED	Class I	Active
Sigvaris Styles Motifs Mosaique 15-20 mmHg	316882	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303079	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313059	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313164	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316872	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312938	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307586	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309585	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312698	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351843	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301935	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303394	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351852	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303515	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307622	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301680	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301690	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301511	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303616	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307853	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308088	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313173	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303277	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307605	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309273	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303075	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303044	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303056	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303396	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	307383	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307608	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301660	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308264	EUDAMED	Class I	Active

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