Skip to content

MAGNETOM Flow.Elite 11851912

by Siemens Healthcare EUDAMEDGUDID

Active European Union

Ref 11851912Model MDR_02_IIa_ERLN H 127_ACDV_Magnetom

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900125UQ Basic UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04068151036732 UDI-DIDate19 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MAGNETOM Flow.Elite
Generic Name
Full-body MRI system, superconducting magnet
Device Name
MDR_02_IIa_ERLN H 127_ACDV_Magnetom
Model / Reference
11851912, MDR_02_IIa_ERLN H 127_ACDV_Magnetom
Primary DI / UDI-DI
04068151036732
Basic UDI-DI
0405686900125UQ
510(k) Number
FDA Product Code
MOS, LNI, LNH
EMDN Code
Z11050104 Closed magnet MRI scanners with magnetic field less than or equal to 2t
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1000
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K252838)

Show all (12)

Other devices from Siemens Healthcare

See all devices from Siemens Healthcare →

Properties

  • Serial Number

Other properties (23)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No