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by Anita Dr. Helbig GmbH 23 variants

Ref M7-6316

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 Number4009706Y06309902ZQ Basic UDI-DI Date17 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  • Withdrawn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
Prosthetic swimwear
Model / Reference
M7-6316
Primary DI / UDI-DI
04058509907920, 04058509907999, 04058509909214, 04058509909078, 04058509909108, 04058509908965, 04058509907906, 04058509909245, 04058509909276, 04058509909009, 04058509908996, 04058509909030, 04058509909238, 04058509907951, 04058509909061, 04058509909221, 04058509908989, 04058509909184, 04058509909023, 04058509909269, 04058509909191, 04058509909177, 04058509909153, 04058509909252, 04058509909146, 04058509909047, 04058509907913, 04058509907968, 04058509909085, 04058509907944, 04058509909122, 04058509909054, 04058509908972, 04058509907937, 04058509907975, 04058509909160, 04058509909207, 04058509909016, 04058509907982, 04058509909139, 04058509909115, 04058509909092
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509907920
04058509907999
04058509909214
04058509909078
04058509909108
04058509908965
04058509907906
04058509909245
04058509909276
04058509909009
04058509908996
04058509909030
04058509909238
04058509907951
04058509909061
04058509909221
04058509908989
04058509909184
04058509909023
04058509909269
04058509909191
04058509909177
04058509909153
04058509909252
04058509909146
04058509909047
04058509907913
04058509907968
04058509909085
04058509907944
04058509909122
04058509909054
04058509908972
04058509907937
04058509907975
04058509909160
04058509909207
04058509909016
04058509907982
04058509909139
04058509909115
04058509909092
EMDN Code
Y063099 Non-extremity prostheses - other
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

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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