Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Medical equipment and related accessories, software and consumables
/
Bioimaging and radiotherapy instruments
/
Diagnostic and interventional radiology instruments
/
Mammography systems
/
Digital mammography systems
Digital mammography systems
Z11030202
45 devices
Devices
Pristina Via
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
GUDID
on market
CareView 750M
Careray Digital Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
NeuCare Mammo DR HD
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Pristina Via
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
Digital Mammography System
HEDY Medical Device Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
CN
Class IIb
CE/MDR
CE/MDD
MammoWave
Umbria Bioengineering Technologies SRL Societa' Benefit
·
,
IT
Class IIa
CE/MDR
CareView 750MT
Careray Digital Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
88000050
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Digital Mammography System
Shenzhen Anke High-Tech Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Digital Mammography System
Shenzhen Anke High-Tech Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
CN
Class IIb
CE/MDR
Pristina Duo
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
Harmonia B
MEDICAL TECHNOLOGIES Ltd
·
,
RU
Class IIb
CE/MDR
Helianthus Dbt
Metaltronica SpA
·
,
IT
Class IIb
CE/MDR
Hestia
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K243420
Active
Cleared 17 Jul 2025
CE/MDR
+1
authorizations
88000752
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
CN
Class IIb
CE/MDD
Helianthus C
Metaltronica SpA
·
,
IT
Class IIb
FDA 510(k)
K202822
Active
Cleared 15 Dec 2021
CE/MDR
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
CN
Class IIb
CE/MDR
Previous
Next