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MAGNETOM Flow.Neo 11878344

by Siemens Healthcare EUDAMEDGUDID

Active European Union

Ref 11878344Model 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 Number04068151047943 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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MAGNETOM Flow.Neo
Generic Name
Full-body MRI system, superconducting magnet
Device Name
MDR_02_IIa_ERLN H 127_ACDV_Magnetom
Model / Reference
11878344, MDR_02_IIa_ERLN H 127_ACDV_Magnetom
Primary DI / UDI-DI
04068151047943
Basic UDI-DI
0405686900125UQ
510(k) Number
FDA Product Code
LNI, LNH, MOS
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

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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