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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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Instruments for the assessment of visual functionality
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Peripheral vision analysers
Peripheral vision analysers
Z1212012003
26 devices
Devices
Compass
Centervue S.P.A.
·
,
IT
Class IIa
FDA 510(k)
K150320
Active
Cleared 30 Jun 2015
CE/MDR
+1
authorizations
Twinfield 3
OCULUS Optikgeräte GmbH
·
,
DE
Class I
CE/MDR
Campitest
Essilor International
·
,
FR
Class I
CE/MDR
Pts 920 By
Optopol Technology Sp Z O O
·
,
PL
Class I
CE/MDR
GUDID
on market
S-Maia
Centervue S.P.A.
·
,
IT
Class IIa
FDA 510(k)
K153181
Active
Cleared 8 Jun 2016
CE/MDD
+1
authorizations
Huvitz
Huvitz Co., Ltd.
·
,
KR
Class I
CE/MDR
GUDID
on market
Henson 9000
Visia Imaging SRL
·
,
IT
Class I
CE/MDR
GUDID
on market
Pts 920
Optopol Technology Sp Z O O
·
,
PL
Class I
CE/MDR
GUDID
on market
Maia
Centervue S.P.A.
·
,
IT
Class IIa
CE/MDD
GUDID
on market
Perimeter SK-950B
Chongqing Sunkingdom Medical Instrument Co., Ltd
·
,
CN
Class I
CE/MDR
Pts 925 W
Optopol Technology Sp Z O O
·
,
PL
Class I
CE/MDR
GUDID
on market
Easyfield C
OCULUS Optikgeräte GmbH
·
,
DE
Class I
CE/MDR
GUDID
on market
Smartfield
OCULUS Optikgeräte GmbH
·
,
DE
Class I
CE/MDR
GUDID
on market
Easyfield S
OCULUS Optikgeräte GmbH
·
,
DE
Class I
CE/MDR
GUDID
on market
Perimeter SK-950C
Chongqing Sunkingdom Medical Instrument Co., Ltd
·
,
CN
Class I
CE/MDR
Eye-Tracking Perimeter FIELDNavigator
FINDEX Inc.
·
,
JP
Class I
CE/MDR
Pts 2000
Optopol Technology Sp Z O O
·
,
PL
Class I
CE/MDR
GUDID
on market
Centerfield 2
OCULUS Optikgeräte GmbH
·
,
DE
Class I
CE/MDR
GUDID
on market
iCare MAIA
Centervue S.P.A.
·
,
IT
Class IIa
FDA 510(k)
K243504
Active
Cleared 17 Mar 2025
CE/MDR
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