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 Maternité transparent 15-20 mmHg	307229	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313369	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312835	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352063	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	357215	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313514	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309593	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301696	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356051	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301628	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309561	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313456	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307848	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301492	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312551	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307567	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313474	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352026	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309876	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312795	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	358513	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303022	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313476	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309518	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	357210	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312914	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303517	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301799	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301489	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313378	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359254	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301934	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359251	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351847	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303617	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309582	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312635	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303140	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313435	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312933	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351844	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313498	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309446	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307222	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303165	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303020	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301676	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307701	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301458	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313383	EUDAMED	Class I	Active

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