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Breast Board

by Aktina Medical Corp 5 variants

Ref 11-220-05Model Breast Board

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B36511229EP Basic UDI-DI +B3651122005UDI-DIDate26 Sep 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Breast Board, 11-220-05
Primary DI / UDI-DI
+B3651122005
Basic UDI-DI
++B36511229EP
Direct Marketing DI
+B3651122005
EMDN Code
Z11010199 Linear accelerators – other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000005935
Authorised representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

From the manufacturer

Manufacturer's product page: Tilt Boards

Other devices from Aktina Medical Corp

See all devices from Aktina Medical Corp →

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