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	312769	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303153	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352057	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	302931	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313471	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303334	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301562	EUDAMED	Class I	Active
Dynaven fin New 20-36 mmHg	361717	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301828	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309564	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316856	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312277	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314035	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313160	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303589	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312942	EUDAMED	Class I	Active
Sigvaris Maternité opaque 15-20 mmHg	307214	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303332	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308262	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312299	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316871	EUDAMED	Class I	Active
Dupraflex Multi étalonnée forte	309706	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303451	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303559	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301886	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312644	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54715	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309548	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301496	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307630	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314036	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313049	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303592	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307796	EUDAMED	Class I	Active
Sigvaris Styles Motifs Mosaique 15-20 mmHg	316884	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309270	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312518	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303070	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	97539	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301588	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303036	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312630	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312625	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54721	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316840	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313201	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303001	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312517	EUDAMED	Class I	Active
Adaptée au mesures essentiel microfibre 15-20 mmHg	320833	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313098	EUDAMED	Class I	Active

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