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	301633	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313350	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313631	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301870	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351839	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	357207	EUDAMED	Class I	Active
Sigvaris Active résistant 15-20 mmHg	307239	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	358575	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314945	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303625	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	97545	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	313260	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308206	EUDAMED	Class I	Active
Sigvaris Active résistant 15-20 mmHg	307254	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303019	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301734	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313470	EUDAMED	Class I	Active
Sigvaris Active résistant 15-20 mmHg	307246	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301832	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303269	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X33508	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307581	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303105	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301469	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309457	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312524	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356988	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307696	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308246	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313013	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X53843	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303598	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	357125	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303012	EUDAMED	Class I	Active
Sigvaris Active confort chaleur 15-20 mmHg	302948	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301475	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316844	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313634	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313052	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303108	EUDAMED	Class I	Active
Dynaven semi-opaque 20-36 mmHg	307854	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313637	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312789	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308200	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301627	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312536	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301768	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301634	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309897	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309214	EUDAMED	Class I	Active

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