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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Ophthalmology instruments
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Ophtalmology assessments and diagnosis instruments
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Fluoroangiographs
Fluoroangiographs
Z12120105
17 devices
Devices
RetCam Envision
Natus Medical Denmark ApS
·
,
DK
Class I
CE/MDR
RetCam Envision
Natus Medical Denmark ApS
·
,
DK
Class I
CE/MDR
RetCam Envision
Natus Medical Denmark ApS
·
,
DK
Class I
CE/MDR
Retinal Camera Trc-50DX
Topcon Corporation
·
,
JP
Class IIa
CE/MDD
Fundus Camera
Wenzhou Gaush Raymond Photoelectric Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Fundus Camera
Wenzhou Gaush Raymond Photoelectric Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Non-Mydriatic Retinal Camera Trc-NW8
Topcon Corporation
·
,
JP
Class IIa
FDA 510(k)
K130289
Active
Cleared 10 May 2013
CE/MDD
Fundus Camera
Wenzhou Gaush Raymond Photoelectric Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
RetCam Envision
Natus Medical Denmark ApS
·
,
DK
Class I
CE/MDR
Non-Mydriatic Retinal Camera NW500
Topcon Corporation
·
,
JP
Class IIa
FDA 510(k)
K221111
Active
Cleared 29 Aug 2022
CE/MDR
+1
authorizations
Retinal Camera Trc-50DX
Topcon Corporation
·
,
JP
Class IIa
CE/MDR
CE/MDD
ICG FILTER ATTACHMENT IF-1 for TRC-50DX
Topcon Corporation
·
,
JP
Class I
CE/MDR
GUDID
on market
External Fixation Target Ef-2
Topcon Corporation
·
,
JP
Class I
CE/MDR
GUDID
on market
RetCam Envision
Natus Medical Denmark ApS
·
,
DK
Class I
CE/MDR
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