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Compliance

OpenRad Germany GmbH and Openrad Services S.A.R.L. are dormant entities that are going to be liquidated. Openrad Services UK Limited does not distribute anything.

  • Biotronics3D’s product 3Dnet is now marketed and sold under the name of B3D Cloud.
  • Visbion’s product Medical PACS (xPACS) is now marketed and sold under the name B3D Cube.

Please note for the US: OpenRad Cloud is not FDA-cleared yet, but in the process of acquiring a clearance.

For compliance information of both manufacturers, please check the below certificates.

Compliance Information of Biotronics 3D Limited.

3Dnet

(c) Biotronics 3D Limited 2004-2024 | All rights reserved
This product is licensed under the terms of the End User Agreement.
descărcare
Class IIa Medical Device
descărcare ()
 EU Authorised Representative
Skyer Medical Imaging S.R.L.
Str. Fabrica de Caramida nr 1A, Lot C, Parcela 36, Sector 1
Bucuresti, Romania
descărcare ()
2797
 
MHRA company registration nr: 0000017323
MHRA Catalogue/Reference (REF): Z110603
 
UDI Issuing Entity: GS1 AISBL
Basic UDI-DI Number: 506075752MEDICALIMAGINGLF
UDI Device Identifier (UDI-DI): 05060757520003
vorschau ch rep
Swiss authorised representative
MedEnvoy
Gotthardstrasse 28, 6302 Zug
Switzerland
 
 
US Agent
Daryl Wisdahl  
MedEnvoy Global Inc.  
10900 Research Blvd, Ste 160C  Unit #2066  
Austin, TX US 78759  
Biotronics 3Dnet Compliance

Compliance Information of Visbion Ltd.

OpenRad Image Cube Compliance

Demonstration Request