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
Dynaven transparent 15-20 mmHg	356038	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313409	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301932	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313364	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301884	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301844	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303554	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316866	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313468	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303516	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X33502	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313455	EUDAMED	Class I	Active
Sigvaris Active confort fraicheur 15-20 mmHg	358571	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312737	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309906	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	351829	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313020	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313348	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	88717	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54636	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313007	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313466	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313061	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303271	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301599	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309452	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	357121	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313488	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313502	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	313616	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	307384	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312617	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301801	EUDAMED	Class I	Active
Sigvaris Active Coton-Bio 55% 15-20 mmHg	352025	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308205	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309186	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312639	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309921	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313402	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	97547	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316834	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301527	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301572	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307602	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312796	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309261	EUDAMED	Class I	Active
Sigvaris Active loisirs 15-20 mmHg	309188	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312762	EUDAMED	Class I	Active
Dupraflex Multi étalonnée légère	309691	EUDAMED	Class I	Active
Delilah by Sigvaris transparent	88704	EUDAMED	Class I	Active

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