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 confort fraicheur 15-20 mmHg	303343	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301723	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308255	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301474	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303106	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301868	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312823	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312634	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313101	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301553	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303021	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	312521	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301596	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313398	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	356969	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301729	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X51513	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352031	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313432	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	88716	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	358518	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301480	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303595	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303422	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303411	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303118	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303408	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351851	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301704	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307224	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313333	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	358517	EUDAMED	Class I	Active
Adaptée au mesures coton 20-36 mmHg	320818	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301931	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301609	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309213	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303466	EUDAMED	Class I	Active
Dynaven fin New 15-20 mmHg	358509	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301731	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	303339	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	313262	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309456	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309264	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301872	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313197	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303011	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301466	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303594	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303076	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301520	EUDAMED	Class I	Active

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