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by Anita Dr. Helbig GmbH 23 variants

Ref M5-6358

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  • Withdrawn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
M5-6358
Primary DI / UDI-DI
04058509739187, 04058509738975, 04058509739194, 04058509739033, 04058509739125, 04058509730412, 04058509739156, 04058509739217, 04058509739286, 04058509739231, 04058509730429, 04058509738999, 04058509730443, 04058509730436, 04058509738982, 04058509739095, 04058509730382, 04058509739002, 04058509739224, 04058509730467, 04058509739064, 04058509739163, 04058509739170, 04058509730405, 04058509739255, 04058509739248, 04058509739040, 04058509730450, 04058509739132, 04058509739057, 04058509739026, 04058509739101, 04058509739071, 04058509730474, 04058509739088, 04058509739149, 04058509739118, 04058509730399, 04058509739200, 04058509739262
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509739187
04058509738975
04058509739194
04058509739033
04058509739125
04058509730412
04058509739156
04058509739217
04058509739286
04058509739231
04058509730429
04058509738999
04058509730443
04058509730436
04058509738982
04058509739095
04058509730382
04058509739002
04058509739224
04058509730467
04058509739064
04058509739163
04058509739170
04058509730405
04058509739255
04058509739248
04058509739040
04058509730450
04058509739132
04058509739057
04058509739026
04058509739101
04058509739071
04058509730474
04058509739088
04058509739149
04058509739118
04058509730399
04058509739200
04058509739262
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