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Essential COMFORTABLE

by Sigvaris AG EUDAMEDGUDID

Active European Union

Ref 320366Model Essential COMFORTABLE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611711ECFBX Basic UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613378198526 UDI-DIDate19 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Essential COMFORTABLE EUDAMED
862N-CUSTOM ECF2 AG Quadrinova UNI °° Savanna GUDID
Generic Name
Compression/pressure sock/stocking, single-use
Model / Ref / Catalog
Essential COMFORTABLE, 320366
Primary DI / UDI-DI
07613378198526
Basic UDI-DI
7611711ECFBX
FDA Product Code
FQL
EMDN Code
M030405 Compression stockings
GMDN Term
Compression/pressure sock/stocking, single-use
Device Class
Class I
Regulation Number
880.5780
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CH-MF-000015565
Authorised representative
Sigvaris GmbH DE-AR-000010016

Related devices

Category: Compression/pressure sock/stocking, single-use

Other devices from Sigvaris AG

See all devices from Sigvaris AG →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No