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Amadeo R-DR

by Oehm und Rehbein GmbH 2 variants

Ref AR2200Model Amadeo R-DR

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42508029AR220027 Basic UDI-DI 04250802900190UDI-DIDate30 Jul 2024RegisteredStatusActive EUDAMED: not on the EU market

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Amadeo R-DR, AR2200
Primary DI / UDI-DI
04250802900190
Basic UDI-DI
42508029AR220027
EMDN Code
Z11039012 X-ray tube assembly
Device Class
Class IIb
Medical Purpose
The Amadeo R-DR is a complete diagnostic radiographic system. The Amadeo R-DR is intended to hold and position the radiation source, the beam limiting device, the X-ray imager and associated devices and the patient during general radiographic procedures.

Manufacturer details

EUDAMED SRN
DE-PR-000037490

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Properties

Other properties (1)

  • Sterile: No