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Sydney

by Anita Dr. Helbig GmbH 4 variants

Ref 1091R

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  • Withdrawn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
1091R
Primary DI / UDI-DI
04009706222859, 04009706435143, 04009706222897, 04009706435112, 04009706434993, 04009706435129, 04009706222866, 04009706435051, 04009706222880, 04009706222941, 04009706222903, 04009706222958, 04009706222835, 04009706222798, 04009706222989, 04009706222781, 04009706222804, 04009706435006, 04009706222934, 04009706222828, 04009706222774, 04009706434986, 04009706222972, 04009706222927, 04009706222873, 04009706222910, 04009706435044, 04009706435150, 04009706222996, 04009706222811, 04009706435105, 04009706222965
Basic UDI-DI
4009706M03049902PN
Direct Marketing DI
04009706222859
04009706435143
04009706222897
04009706435112
04009706434993
04009706435129
04009706222866
04009706435051
04009706222880
04009706222941
04009706222903
04009706222958
04009706222835
04009706222798
04009706222989
04009706222781
04009706222804
04009706435006
04009706222934
04009706222828
04009706222774
04009706434986
04009706222972
04009706222927
04009706222873
04009706222910
04009706435044
04009706435150
04009706222996
04009706222811
04009706435105
04009706222965
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

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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