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Compliance

Biotronics3D’s product 3Dnet is marketed and sold under the name of 3Dnet.

Visbion’s Image Cube is now marketed and sold under the name Biotronics3D Cube.

Please note for the US: 3Dnet (also known as OpenRad Cloud) was FDA-cleared on 2024.

Compliance Information of Biotronics 3D Limited.

3Dnet

© Biotronics 3D Limited 2004-2026 | All rights reserved
This product is licensed under the terms of the End User Agreement.
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Class IIa Medical Device
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Manufacturer
Biotronics 3D Limited
10 Upper Berkeley Street
London | W1H 7PE
United Kingdom
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 EU Authorised Representative
Skyer Medical Imaging S.R.L.
Str. Fabrica de Caramida nr 1A, Lot C, Parcela 36, Sector 1
Bucuresti, Romania

SRN: RO-AR-000049393

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2797
 
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  

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