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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Various instruments for radiodiagnostics and interventional procedures
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Mobile radiographic units
Mobile radiographic units
Z11039016
193 devices
JET 32 Plus
BMI Biomedical International S.r.l.
·
,
Italy
Class IIb
CE/MDR
Proslide 32 B
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
Sensor RXS 1000
Rolence Enterprise Inc.
·
,
Taiwan
Class IIb
FDA 510(k)
K202369
Active
Cleared 15 Sep 2021
CE/MDD
Ultra 1060HF
ECORAY Co., Ltd.
·
,
South Korea
Class IIb
CE/MDD
Portable X-ray unit
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
China
Class IIb
FDA 510(k)
K200637
Active
Cleared 9 Jul 2020
CE/MDR
+1
authorizations
Portable dental X-ray system
Dexcowin
·
,
South Korea
Class IIb
CE/MDD
GUDID
on market
Exairo Plus Dr
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
Portable X-ray unit
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
MOBILETT Impact
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Accord DR40
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
PROSLIDE 32 B System
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Compact Dr Plus
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
Tmb 400
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
REVEAL MOBI-PRO 40kW
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
Amadeo M-DR mini
Oehm Und Rehbein GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Diagnostic X-ray Generaor with Tube Assembly
Kuanteng (Liaoning) Medical Devices Co., Ltd.
·
,
China
Class IIb
CE/MDD
Rafale B 32
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
Rafale Rdr
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
Tmb 320 Dr
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
REVEAL MOBI-PRO 32kW
Technix S.p.A.
·
,
Italy
Class IIb
CE/MDR
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