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 transparent 15-20 mmHg	309884	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356974	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301841	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301838	EUDAMED	Class I	Active
Sigvaris Active Coton 15-20 mmHg	357252	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301695	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303388	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313356	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301700	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307616	EUDAMED	Class I	Active
Sigvaris Active Coton 15-20 mmHg	357257	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309525	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314040	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309274	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307788	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303253	EUDAMED	Class I	Active
Venoped	309057	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303142	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303014	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302952	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	307790	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301669	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309208	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301620	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352052	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301751	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303275	EUDAMED	Class I	Active
Adaptée au mesures essentiel microfibre 15-20 mmHg	320844	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303445	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308258	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301736	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312598	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312767	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301875	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303540	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307707	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303155	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301831	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313303	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	359249	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301791	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313429	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312864	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309152	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303599	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301486	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313439	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301808	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303280	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303441	EUDAMED	Class I	Active

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