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 opaque 15-20 mmHg	301498	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301557	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302956	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312535	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312709	EUDAMED	Class I	Active
Adaptée au mesures coton 20-36 mmHg	320822	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314426	EUDAMED	Class I	Active
Dupraflex Multi étalonnée légère	309701	EUDAMED	Class I	Active
Dupraflex Multi étalonnée légère	309698	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316861	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303026	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312851	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303201	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309514	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312809	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301594	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307857	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	357127	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301810	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312739	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309489	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303250	EUDAMED	Class I	Active
Dynaven fin New 20-36 mmHg	361709	EUDAMED	Class I	Active
Sigvaris ATH	309427	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309508	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313015	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313125	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309569	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309189	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309891	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303491	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303208	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	88712	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301451	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54657	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309215	EUDAMED	Class I	Active
Sigvaris Maternité opaque 15-20 mmHg	307220	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320854	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301649	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313299	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312533	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309179	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351833	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312308	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314425	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352043	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303468	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301709	EUDAMED	Class I	Active
Dupraflex Multi étalonnée forte	309702	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313112	EUDAMED	Class I	Active

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