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by Anita Dr. Helbig GmbH 23 variants

Ref M4-6355

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  • Withdrawn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
M4-6355
Primary DI / UDI-DI
04058509612619, 04058509612596, 04058509631313, 04058509631405, 04058509631153, 04058509612565, 04058509612626, 04058509612572, 04058509612589, 04058509631269, 04058509631238, 04058509612534, 04058509631146, 04058509631375, 04058509631191, 04058509612541, 04058509631122, 04058509631306, 04058509631160, 04058509631351, 04058509631290, 04058509631368, 04058509631337, 04058509631184, 04058509631382, 04058509631108, 04058509631092, 04058509631276, 04058509631207, 04058509631252, 04058509631283, 04058509631320
Basic UDI-DI
4009706Y06309902ZQ
Direct Marketing DI
04058509612619
04058509612596
04058509631313
04058509631405
04058509631153
04058509612565
04058509612626
04058509612572
04058509612589
04058509631269
04058509631238
04058509612534
04058509631146
04058509631375
04058509631191
04058509612541
04058509631122
04058509631306
04058509631160
04058509631351
04058509631290
04058509631368
04058509631337
04058509631184
04058509631382
04058509631108
04058509631092
04058509631276
04058509631207
04058509631252
04058509631283
04058509631320
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