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Compreflex

by Sigvaris Inc. 7 variants

Part of a family of 8 devices: see the family page

Ref 351428Model Compreflex

Compreflex (351428) is a Class I device made by Sigvaris, Inc., registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI 0745129COMPREFLEX2L), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0745129COMPREFLEX2L Basic UDI-DI 00745129284985UDI-DIDate2 Jun 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  • Withdrawn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
Compreflex, 351428
Primary DI / UDI-DI
00745129284985
Basic UDI-DI
0745129COMPREFLEX2L
EMDN code
M030405 Compression stockings
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000048820
Authorised representative
Sigvaris GmbH DE-AR-000010016

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Properties

Other properties (14, all answered No)