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by Anita Dr. Helbig GmbH 9 variants

Ref M3-6418

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  • Withdrawn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
M3-6418
Primary DI / UDI-DI
04058509547058, 04058509547133, 04058509547126, 04058509547164, 04058509547102, 04058509547171, 04058509547140, 04058509547232, 04058509547027, 04058509547096, 04058509547065, 04058509547157, 04058509547225, 04058509547089, 04058509547041, 04058509547188, 04058509547034, 04058509547072, 04058509547119, 04058509547003, 04058509547218, 04058509547010, 04058509547195, 04058509547201
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509547058
04058509547133
04058509547126
04058509547164
04058509547102
04058509547171
04058509547140
04058509547232
04058509547027
04058509547096
04058509547065
04058509547157
04058509547225
04058509547089
04058509547041
04058509547188
04058509547034
04058509547072
04058509547119
04058509547003
04058509547218
04058509547010
04058509547195
04058509547201
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

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