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Vantage Adapter for Mayfield

by Elekta Solutions AB

Part of a family of 12 devices: see the family page

Ref 1578097Model Leksell Vantage Stereotactic System (Class I)

Vantage Adapter for Mayfield (1578097) is a Class I device made by Elekta Solutions Ab, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI 073402015BUDI000000019PS), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number073402015BUDI000000019PS Basic UDI-DI 07340201503928UDI-DIDate24 Jun 2026RegisteredStatusActive

Official records

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  • Withdrawn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
Leksell Vantage Stereotactic System
Model / reference
Leksell Vantage Stereotactic System (Class I), 1578097
Primary DI / UDI-DI
07340201503928
Basic UDI-DI
073402015BUDI000000019PS
Direct marketing DI
07340201503928
EMDN code
Z12100601 Stereotactic neurosurgery systems
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000002125

Similar devices in this category

Other devices filed under STEREOTACTIC NEUROSURGERY INSTRUMENTS.

Other devices from Elekta Solutions Ab

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Properties

Other properties (14, all answered No)