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	301917	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316845	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313423	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313363	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313106	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313645	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352039	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	307382	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303071	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313492	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312932	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	358570	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312718	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309180	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313347	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303002	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54695	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54655	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303207	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309578	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313038	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313168	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313509	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X53817	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312849	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303340	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303270	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301758	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313105	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313404	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316850	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X53816	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303464	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312685	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307856	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301559	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356971	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313513	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301610	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303178	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303522	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303504	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313338	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312724	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	309110	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54618	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303041	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303403	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313499	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303483	EUDAMED	Class I	Active

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