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	312707	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356981	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351834	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303097	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308241	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313653	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54622	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312520	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X53858	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303215	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303237	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312290	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308253	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316847	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313198	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309572	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309889	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301637	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309502	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312286	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303217	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	357218	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301719	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303428	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314422	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312906	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	313261	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309584	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303084	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302963	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312797	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307683	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301629	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312858	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313287	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307851	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312282	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303192	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301899	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307858	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303281	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303545	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356978	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312736	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301891	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303031	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303435	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301602	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301490	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301773	EUDAMED	Class I	Active

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