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AK550 Table Top

by Aktina Medical Corp 4 variants

Ref 51-230, 51-260, 51-220, 51-201, 11-216, 11-218-LS, 51-250, 11-216SModel AK550 Table Top

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B36551200FB Basic UDI-DI Date27 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  • Withdrawn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

Device Name
Mesh Insert. Carbon Fiber. Central Opening.
Model / Reference
AK550 Table Top, 51-230, 51-260, 51-220, 51-201, 11-216, 11-218-LS, 51-250, 11-216S
Primary DI / UDI-DI
+B365512300, +B365512600, +B365512200, +B365512010, +B365112160, +B36511218LS0, +B365512500, +B36511216S0
Basic UDI-DI
++B36551200FB
Direct Marketing DI
+B365512300
+B365512600
+B365512200
+B365512010
+B365112160
+B36511218LS0
+B365512500
+B36511216S0
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

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