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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 optical biometers
Computerised optical biometers
Z12120102
22 devices
Devices
Optical Biometer
Shanghai Mediworks Precision Instruments Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Myo 200
Carl Zeiss Meditec (Suzhou) Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Lenstar LS 900
Haag-Streit AG
·
,
CH
Class IIa
CE/MDR
CE/MDD
+1
authorizations
Lenstar LS 900 APS
Haag-Streit AG
·
,
CH
Class IIa
CE/MDD
GUDID
on market
Aladdin HW3.0
Visia Imaging SRL
·
,
IT
Class IIa
FDA 510(k)
K131567
Active
Cleared 5 Jun 2014
FDA 510(k)
K160327
Active
Cleared 5 Oct 2016
+2
authorizations
ARGOS ver1.5
santec OIS Corporation
·
,
JP
Class IIa
FDA 510(k)
K150754
Active
Cleared 2 Oct 2015
FDA 510(k)
K191051
Active
Cleared 16 May 2019
+2
authorizations
EyeSuite Myopia
Haag-Streit AG
·
,
CH
Class IIa
CE/MDR
1000313788
Active
Valid to Jul 2027
EyeSuite IOL
Haag-Streit AG
·
,
CH
Class IIb
CE/MDR
1000313788
Active
Valid to Jul 2027
CE/MDR
170775962
Active
Valid to Jul 2027
+1
authorizations
Skaner biometryczny PIROP
Echo-Son SA
·
,
PL
Class IIa
CE/MDD
T-Cone
Haag-Streit AG
·
,
CH
Class I
CE/MDR
CE/MDD
+1
authorizations
Eyestar 900
Haag-Streit AG
·
,
CH
Class IIa
CE/MDD
Huvitz
Huvitz Co., Ltd.
·
,
KR
Class IIa
CE/MDR
GUDID
on market
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