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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Echography instruments
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Ultrasound scanners
/
Handheld ultrasound scanners
Handheld ultrasound scanners
Z11040106
119 devices
EdgeFlow UH10L
EdgeCare Inc.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Aco Smartcare
Aco Healthcare Co., Ltd.
·
,
Taiwan
Class IIa
CE/MDR
GUDID
on market
Pulsenmore ES
Pulsenmore Ltd
·
,
Israel
Class IIa
CE/MDR
GUDID
on market
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
Butterfly iQ+ Ultrasound System
Butterfly Network, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Pocket Ultrasound System
Beijing Konted Medical Technology Co., Ltd
·
,
China
Class IIa
CE/MDR
CN24/00006331
Active
Valid to Oct 2029
Pocket Ultrasound System
Beijing Konted Medical Technology Co., Ltd
·
,
China
Class IIa
CE/MDR
CN24/00006331
Active
Valid to Oct 2029
Pulsenmore ES
Pulsenmore Ltd
·
,
Israel
Class IIa
CE/MDR
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
Wireless Diagnostic Ultrasound Device
Dawei Medical (Jiangsu) Co., Ltd.
·
,
China
Class IIa
CE/MDR
Handheld Ultrasound Scanners
Bionet Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
2023-MDR/QS-030
Active
Valid to Oct 2028
Pocket Ultrasound System
Beijing Konted Medical Technology Co., Ltd
·
,
China
Class IIa
CE/MDR
CN24/00006331
Active
Valid to Oct 2029
Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×4
K220051
Active
Cleared 4 Mar 2022
CE/MDR
+1
authorizations
Wireless Diagnostic Ultrasound Device
Dawei Medical (Jiangsu) Co., Ltd.
·
,
China
Class IIa
CE/MDR
Kosmos Bridge
EchoNous
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Pocket Ultrasound System
Beijing Konted Medical Technology Co., Ltd
·
,
China
Class IIa
CE/MDR
CN24/00006331
Active
Valid to Oct 2029
Vinno
Vinno Technology (Suzhou) Co., Ltd
·
,
China
Class IIa
CE/MDR
Chison
CHISON Medical Technologies Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
U Lite Pro
Sonoscanner
·
,
France
Class IIa
CE/MDR
GUDID
on market
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