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by Anita Dr. Helbig GmbH 23 variants

Ref M5-6366

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  • Withdrawn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
M5-6366
Primary DI / UDI-DI
04058509709364, 04058509709432, 04058509715105, 04058509715020, 04058509715280, 04058509715266, 04058509715198, 04058509715112, 04058509715143, 04058509715136, 04058509715068, 04058509715037, 04058509715167, 04058509715297, 04058509715327, 04058509709388, 04058509715150, 04058509715099, 04058509715051, 04058509715310, 04058509715082, 04058509715303, 04058509709395, 04058509715174, 04058509715334, 04058509709418, 04058509715259, 04058509715204, 04058509715273, 04058509709449, 04058509715211, 04058509709425, 04058509715228, 04058509709456, 04058509709401, 04058509715129, 04058509715242, 04058509715075, 04058509715044, 04058509715181, 04058509709371, 04058509715235
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509709364
04058509709432
04058509715105
04058509715020
04058509715280
04058509715266
04058509715198
04058509715112
04058509715143
04058509715136
04058509715068
04058509715037
04058509715167
04058509715297
04058509715327
04058509709388
04058509715150
04058509715099
04058509715051
04058509715310
04058509715082
04058509715303
04058509709395
04058509715174
04058509715334
04058509709418
04058509715259
04058509715204
04058509715273
04058509709449
04058509715211
04058509709425
04058509715228
04058509709456
04058509709401
04058509715129
04058509715242
04058509715075
04058509715044
04058509715181
04058509709371
04058509715235
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