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 Spécialiste Anti-Thrombose AT2 15-20 mmHg	309581	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320882	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301871	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X53835	EUDAMED	Class I	Active
Sigvaris ATH	309435	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303511	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	361936	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356966	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X49894	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303025	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301487	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307692	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320881	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313394	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303377	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312879	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312840	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301712	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313430	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312699	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309504	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303473	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312735	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312645	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313312	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	309112	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301455	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312768	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313370	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	357047	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359263	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309482	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301903	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312918	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313462	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303596	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313644	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301732	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303059	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307697	EUDAMED	Class I	Active
Venoped	309061	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301888	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312562	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313486	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	361932	EUDAMED	Class I	Active
Sigvaris Bande anti-œdème Médica	309689	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356985	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301900	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301744	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312805	EUDAMED	Class I	Active

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