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Sydney

by Anita Dr. Helbig GmbH 4 variants

Ref 1091L

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4009706M03049902PN Basic UDI-DI Date8 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Compression bras
Model / Reference
1091L
Primary DI / UDI-DI
04009706435136, 04009706435082, 04009706222736, 04009706222668, 04009706222590, 04009706435075, 04009706222613, 04009706222675, 04009706435013, 04009706222767, 04009706222576, 04009706222538, 04009706435167, 04009706435099, 04009706222750, 04009706222712, 04009706435037, 04009706222705, 04009706435020, 04009706222729, 04009706434962, 04009706222644, 04009706222552, 04009706434979, 04009706222699, 04009706222637, 04009706222651, 04009706222743, 04009706222583, 04009706222569, 04009706222545, 04009706222620
Basic UDI-DI
4009706M03049902PN
Direct Marketing DI
04009706435136
04009706435082
04009706222736
04009706222668
04009706222590
04009706435075
04009706222613
04009706222675
04009706435013
04009706222767
04009706222576
04009706222538
04009706435167
04009706435099
04009706222750
04009706222712
04009706435037
04009706222705
04009706435020
04009706222729
04009706434962
04009706222644
04009706222552
04009706434979
04009706222699
04009706222637
04009706222651
04009706222743
04009706222583
04009706222569
04009706222545
04009706222620
EMDN Code
M030499 Elastic bandages, support and compression - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000012631

Related devices

Category: Compression/pressure sock/stocking, reusable

Other devices from Anita Dr. Helbig GmbH

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Properties

Other properties (13)

  • 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