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Ayla

by Anita Dr. Helbig GmbH 3 variants

Ref 1189.6

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 Number4009706M03049902PN Basic UDI-DI Date8 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  • Withdrawn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
Compression bras
Model / Reference
1189.6
Primary DI / UDI-DI
04058509768347, 04058509768330, 04058509335730, 04058509768286, 04058509748042, 04058509768415, 04058509768361, 04058509335778, 04058509748035, 04058509748097, 04058509768316, 04058509768279, 04058509335761, 04058509748103, 04058509768262, 04058509335716, 04058509335754, 04058509768392, 04058509748011, 04058509335785, 04058509517921, 04058509768385, 04058509517938, 04058509335723, 04058509748073, 04058509768422, 04058509768378, 04058509768446, 04058509768323, 04058509748066
Basic UDI-DI
4009706M03049902PN
Direct Marketing DI
04058509768347
04058509768330
04058509335730
04058509768286
04058509748042
04058509768415
04058509768361
04058509335778
04058509748035
04058509748097
04058509768316
04058509768279
04058509335761
04058509748103
04058509768262
04058509335716
04058509335754
04058509768392
04058509748011
04058509335785
04058509517921
04058509768385
04058509517938
04058509335723
04058509748073
04058509768422
04058509768378
04058509768446
04058509768323
04058509748066
EMDN Code
M030499 Elastic bandages, support and compression - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000012631

Related devices

Category: Compression/pressure sock/stocking, reusable

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