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Allround SoftLite

by Anita Dr. Helbig GmbH 2 variants

Ref 1037X

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4009706Y06301801XR 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  • Withdrawn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
Breast prostheses, external
Model / Reference
1037X
Primary DI / UDI-DI
04058509774027, 04058509768217, 04058509774072, 04058509768194, 04058509774119, 04058509768163, 04058509768231, 04058509768187, 04058509774041, 04058509774034, 04058509768149, 04058509774096, 04058509774003, 04058509774010, 04058509768170, 04058509774102, 04058509774089, 04058509768156, 04058509768200, 04058509768132, 04058509768125
Basic UDI-DI
4009706Y06301801XR
Direct Marketing DI
04058509774027
04058509768217
04058509774072
04058509768194
04058509774119
04058509768163
04058509768231
04058509768187
04058509774041
04058509774034
04058509768149
04058509774096
04058509774003
04058509774010
04058509768170
04058509774102
04058509774089
04058509768156
04058509768200
04058509768132
04058509768125
EMDN Code
Y063018 External breast prostheses
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