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Active Ocean

by Anita Dr. Helbig GmbH 3 variants

Ref 1082X

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  • Withdrawn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
1082X
Primary DI / UDI-DI
04009706102205, 04009706102274, 04009706020271, 04009706020202, 04009706020264, 04009706020233, 04009706020288, 04009706020226, 04009706102281, 04009706020196, 04009706020172, 04009706102250, 04009706020240, 04009706102212, 04009706102311, 04009706102267, 04009706020257, 04009706102298
Basic UDI-DI
4009706Y06301801XR
Direct Marketing DI
04009706102205
04009706102274
04009706020271
04009706020202
04009706020264
04009706020233
04009706020288
04009706020226
04009706102281
04009706020196
04009706020172
04009706102250
04009706020240
04009706102212
04009706102311
04009706102267
04009706020257
04009706102298
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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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