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
Dynaven fin New 15-20 mmHg	359269	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303593	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301860	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313623	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316851	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301920	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303609	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320862	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309206	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309563	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320877	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313434	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301464	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307787	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359244	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303219	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351840	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54697	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313311	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312945	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303569	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303218	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359227	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307226	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309893	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301716	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54696	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301857	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312794	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320883	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301761	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312731	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309177	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312803	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301536	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351842	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303048	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312854	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303035	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309174	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352035	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316835	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307702	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301826	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301460	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314424	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359272	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307784	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54719	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303263	EUDAMED	Class I	Active

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