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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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Computerised corneal topographs
Computerised corneal topographs
Z12120123
29 devices
Devices
Myopia Master
OCULUS Optikgeräte GmbH
·
,
DE
Class IIa
CE/MDR
medmont meridia™ Advanced Topographer | Vantage
Medmont International Pty.Ltd.
·
,
AU
Class IIa
CE/MDR
GUDID
on market
Myopia Master
OCULUS Optikgeräte GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
Huvitz
Huvitz Co., Ltd.
·
,
KR
Class IIa
CE/MDR
GUDID
on market
Myopia Master
Open recall
OCULUS Optikgeräte GmbH
·
,
DE
Class IIa
FDA 510(k)
K202989
Active
Cleared 14 Jul 2021
CE/MDR
Precisio
iVis Technologies S.r.l.
·
,
IT
Class IIb
CE/MDD
Myopia Master
OCULUS Optikgeräte GmbH
·
,
DE
Class IIa
CE/MDR
medmont meridia™ Advanced Topographer | Classic
Medmont International Pty.Ltd.
·
,
AU
Class IIa
CE/MDR
GUDID
on market
Allegro Topolyzer
Alcon Laboratories, Inc.
·
,
US
Class IIa
CE/MDR
TERA Dry Eye Imager
Visia Imaging SRL
·
,
IT
Class IIa
CE/MDR
Corneal Topographer
Wenzhou Gaush Raymond Photoelectric Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
OS1000 - Topografo Corneale
Sbm Sistemi SRL
·
,
IT
Class IIa
CE/MDR
ES600X - Topografo Corneale
Sbm Sistemi SRL
·
,
IT
Class IIa
CE/MDR
Pentacam AXL
OCULUS Optikgeräte GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
TERA Dry Eye Imager
Visia Imaging SRL
·
,
IT
Class IIa
CE/MDR
GUDID
on market
Tde - Topografo Corneale
Sbm Sistemi SRL
·
,
IT
Class IIa
CE/MDR
Corneal Topographer SK-7000B
Chongqing Sunkingdom Medical Instrument Co., Ltd
·
,
CN
Class I
CE/MDR
Pentacam
OCULUS Optikgeräte GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
Antares+
Costruzione Strumenti Oftalmici C.S.O. Srl
·
,
IT
Class IIa
CE/MDD
Myopia Expert 700
Visia Imaging SRL
·
,
IT
Class IIa
FDA 510(k)
K211868
Active
Cleared 1 Mar 2022
FDA 510(k)
K222933
Active
Cleared 29 Jun 2023
+1
authorizations
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