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Sedecal Mill-El-B

by Sedecal., Sa.

Part of a family of 50 devices: see the family page

Ref MILL-EL-BModel MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f

Sedecal Mill-El-B is a device classified as Class IIb in the EU and Class II in the US made by Sedecal., Sa., registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 843604600SYSTEMPS) and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 08436046001015), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number843604600SYSTEMPS Basic UDI-DI 08436046001015UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08436046001015 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 843604600SYSTEMPS registered 7 Jul 2026 Active
  • FDA GUDID UDI-DI 08436046001015 listed 28 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08436046001015
  2. Registered EUDAMED 843604600SYSTEMPS

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Sedecal
Generic name
Basic diagnostic x-ray system table, powered
Device name
Radiographic System
Model / reference
MILL-EL-B, MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f
Primary DI / UDI-DI
08436046001015
Basic UDI-DI
843604600SYSTEMPS
FDA product code
IZZ
EMDN code
Z11039005 Radiogenic complexes
GMDN term
Basic diagnostic x-ray system table, powered
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1980
EU registration type
Standard device
EU market of registration
Spain
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: Basic diagnostic x-ray system table, powered

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)