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Essential COMFORTABLE

by Sigvaris AG 1,000+ variants

Part of a family of 2,500+ devices: see the family page

Ref 69564Model Essential COMFORTABLE

Essential COMFORTABLE (69564) is a Class I device made by Sigvaris AG, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 7611711ECFBX), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611711ECFBX Basic UDI-DI 07611711695640UDI-DIDate20 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Essential COMFORTABLE, 69564
Primary DI / UDI-DI
07611711695640
Basic UDI-DI
7611711ECFBX
EMDN code
M030405 Compression stockings
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

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Properties

Other properties (14, all answered No)