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Amadeo M-DR mini

by Oehm und Rehbein GmbH

Ref AM1100Model Amadeo M-DR mini

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42508029AM1100XZ Basic UDI-DI 04250802900008UDI-DIDate25 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04250802900008 UDI-DI Date13 Dec 2023ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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

Generic Name
Mobile basic diagnostic x-ray system, digital
Model / Ref / Catalog
Amadeo M-DR mini EUDAMED
AM1100 EUDAMED
Amadeo M-AX GUDID
AM1000 GUDID
Primary DI / UDI-DI
04250802900008
Basic UDI-DI
42508029AM1100XZ
EMDN Code
Z11039016 Mobile radiographic units
GMDN Term
Mobile basic diagnostic x-ray system, digital
Device Class
Class IIb
Medical Purpose
The Amado M-DR mini system is intended to be used for mobile digital radiography.
GUDID distribution status
In Commercial Distribution
Size
Weight — 79 Kilogram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Amadeo M-DR mini
AM1100
GUDID
Amadeo M-AX

Manufacturer details

EUDAMED SRN
DE-PR-000037490

Other devices from Oehm Und Rehbein GmbH

See all devices from Oehm Und Rehbein GmbH →

Properties

  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No