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Berlin

by Anita Dr. Helbig GmbH 3 variants

Ref 0054

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  • Withdrawn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
0054
Primary DI / UDI-DI
04009706504344, 04009706504290, 04009706593584, 04009706504238, 04058509250842, 04009706504207, 04009706504283, 04058509250934, 04058509250880, 04009706593485, 04058509250835, 04009706504306, 04009706595618, 04058509250927, 04058509250873, 04009706595670, 04009706593546, 04009706593621, 04009706593508, 04009706504320, 04009706504375, 04058509250828, 04058509251009, 04009706504269, 04009706595649, 04009706595663, 04009706504313, 04009706593645, 04009706504245, 04009706595687, 04058509250910, 04009706595656, 04009706504214, 04009706504337, 04058509250941, 04009706504177, 04058509250996, 04058509250972, 04058509250965, 04058509250897
Basic UDI-DI
4009706M03049902PN
Direct Marketing DI
04009706504344
04009706504290
04009706593584
04009706504238
04058509250842
04009706504207
04009706504283
04058509250934
04058509250880
04009706593485
04058509250835
04009706504306
04009706595618
04058509250927
04058509250873
04009706595670
04009706593546
04009706593621
04009706593508
04009706504320
04009706504375
04058509250828
04058509251009
04009706504269
04009706595649
04009706595663
04009706504313
04009706593645
04009706504245
04009706595687
04058509250910
04009706595656
04009706504214
04009706504337
04058509250941
04009706504177
04058509250996
04058509250972
04058509250965
04058509250897
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