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Upgrade Kit XA61A

by Siemens Healthcare GmbH

Ref 11689984Model MDR_02_IIa_ERLN H 127_ACDV_SaMD

Upgrade Kit XA61A (11689984) is a Class IIa device made by Siemens Healthcare GmbH, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 0405686900128UW), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405686900128UW Basic UDI-DI 04056869985251UDI-DIDate10 Jul 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
MDR_02_IIa_ERLN H 127_ACDV_SaMD
Model / reference
MDR_02_IIa_ERLN H 127_ACDV_SaMD, 11689984
Primary DI / UDI-DI
04056869985251
Basic UDI-DI
0405686900128UW
EMDN code
Z11050192 Magnetic resonance (MR) systems - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006122

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Properties

Other properties (14, all answered No)