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Luminos dRF Max 10762471

by Siemens Healthcare GmbH

Ref 10762471Model MDD_16_II b_ERLN H 127_Fluoro_digital_dRF

Luminos dRF Max 10762471 is a medical device (EU MDD Class IIb; FDA Class II; FDA product code OWB, Interventional fluoroscopic x-ray system; EMDN category fluoroscopy devices) made by Siemens Healthcare GmbH, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-04056869009155) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869009155), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04056869009155 Basic UDI-DI 04056869009155UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869009155 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04056869009155 registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 04056869009155 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04056869009155
  2. Registered EUDAMED B-04056869009155

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Luminos dRF Max
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Device name
MDD_16_II b_ERLN H 127_Fluoro_digital_dRF
Model / reference
10762471, MDD_16_II b_ERLN H 127_Fluoro_digital_dRF
Primary DI / UDI-DI
04056869009155
Basic UDI-DI
B-04056869009155
FDA product code
OWB
EMDN code
Z11039009 Fluoroscopy devices
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Similar devices in this category

Other devices filed under FLUOROSCOPY DEVICES.

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Serial number
Other properties (24, all answered No)