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Pure fresh

by Anita Dr. Helbig GmbH 2 variants

Ref 1086X

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 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  • Withdrawn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
1086X
Primary DI / UDI-DI
04058509405211, 04009706642787, 04009706642749, 04058509405273, 04009706642817, 04058509405204, 04009706642831, 04009706642794, 04009706642725, 04058509405228, 04058509405310, 04058509405242, 04009706642848, 04009706642770, 04009706642824, 04009706642732, 04009706642800, 04058509405198, 04058509405259, 04058509405303, 04009706642763
Basic UDI-DI
4009706Y06301801XR
Direct Marketing DI
04058509405211
04009706642787
04009706642749
04058509405273
04009706642817
04058509405204
04009706642831
04009706642794
04009706642725
04058509405228
04058509405310
04058509405242
04009706642848
04009706642770
04009706642824
04009706642732
04009706642800
04058509405198
04058509405259
04058509405303
04009706642763
EMDN Code
Y063018 External breast prostheses
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000012631

Other devices from Anita Dr. Helbig GmbH

See all devices from Anita Dr. Helbig GmbH →

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