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 Advance 14-18 mmHg	X54722	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313145	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301533	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312917	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308091	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313385	EUDAMED	Class I	Active
Sigvaris Maternité transparent 15-20 mmHg	307225	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320879	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	309875	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303282	EUDAMED	Class I	Active
Adaptée au mesures essentiel semi transparent 15-20 mmHg	320847	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312910	EUDAMED	Class I	Active
Sigvaris Styles Motifs Carreaux 15-20 mmHg	316857	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303082	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313310	EUDAMED	Class I	Active
Sigvaris Essentiel coton 20-36 mmHg	303268	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307582	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313382	EUDAMED	Class I	Active
Sigvaris Styles colors 15-20 mmHg	314427	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301784	EUDAMED	Class I	Active
Sigvaris Spécialiste DiabtX 20-36 mmHg	308087	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301569	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	307573	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303610	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313507	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313325	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303015	EUDAMED	Class I	Active
Dynaven transparent 15-20 mmHg	303499	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301925	EUDAMED	Class I	Active
Sigvaris Styles Motifs Plumetis 15-20 mmHg	316843	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 10-15 mmHg	313327	EUDAMED	Class I	Active
Sigvaris Spécialiste Expert 20-36 mmHg	309495	EUDAMED	Class I	Active
Sigvaris Styles marinière 15-20 mmHg	309117	EUDAMED	Class I	Active
Sigvaris Advance 14-18 mmHg	X54635	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303588	EUDAMED	Class I	Active
Sigvaris Essentiel microfibre 15-20 mmHg	303116	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303572	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313371	EUDAMED	Class I	Active
Damart by Sigvaris Group 70D	309262	EUDAMED	Class I	Active
Sigvaris Styles Motifs Mosaique 15-20 mmHg	316887	EUDAMED	Class I	Active
Sigvaris ATH	309442	EUDAMED	Class I	Active
Sigvaris Essentiel coton 15-20 mmHg	303193	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	312844	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301558	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	303622	EUDAMED	Class I	Active
Sigvaris Styles transparent 15-20 mmHg	301752	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 15-20 mmHg	313143	EUDAMED	Class I	Active
Sigvaris Styles opaque 15-20 mmHg	301499	EUDAMED	Class I	Active
Dynaven semi-opaque 15-20 mmHg	357045	EUDAMED	Class I	Active
Sigvaris Essentiel semi-transparent 20-36 mmHg	313372	EUDAMED	Class I	Active

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