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 Active Coton-Bio 55% 15-20 mmHg	361934	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303492	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313619	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303054	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303471	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303256	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303060	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313172	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301677	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303225	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313199	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303619	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301820	EUDAMED	Class I	Active
Sigvaris Maternité opaque 15-20 mmHg	307215	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313625	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313343	EUDAMED	Class I	Active
Sigvaris Spécialiste Anti-Thrombose AT2 15-20 mmHg	309580	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303509	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301714	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313157	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312607	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301785	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308195	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303123	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302946	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307604	EUDAMED	Class I	Active
Sigvaris Active résistant 15-20 mmHg	307248	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301893	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313294	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307233	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312779	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307232	EUDAMED	Class I	Active
Adaptée au mesures essentiel microfibre 15-20 mmHg	320845	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307682	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312765	EUDAMED	Class I	Active
Venoped	309063	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313504	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312804	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312537	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312627	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312725	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302966	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303328	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X53836	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303040	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	356030	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359223	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	88709	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303418	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301771	EUDAMED	Class I	Active

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