Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Medical equipment and related accessories, software and consumables
/
Instruments for functional explorations and therapeutic interventions
/
Ophthalmology instruments
Ophthalmology instruments
Z1212
3,631 devices
Subcategories
3
Z121201
Ophtalmology assessments and diagnosis instruments
2,827
devices
›
Z121202
Therapeutic and surgical ophtholmological treatments instruments
579
devices
›
Z121290
Various ophtalmology instruments
225
devices
›
Devices
Ophthalmoscope
Foshan Any Home Care Medical Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
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
VisioSystem
Siem Biomedicale
·
,
FR
Class IIa
CE/MDD
NOVA Vision Testing System
Diopsys, Inc.
·
,
US
Class IIa
CE/MDD
GUDID
on market
MonBabyBox
Metrovision
·
,
FR
Class IIa
CE/MDR
BE26/00000270
Active
Valid to Sep 2031
MonPackONE
metrovision SAS
·
,
FR
Class IIa
CE/MDR
BE26/00000270
Active
Valid to Sep 2031
MonCvONE
metrovision SAS
·
,
FR
Class IIa
CE/MDR
BE26/00000270
Active
Valid to Sep 2031
FDA 510(k)
K212936
Active
Cleared 21 Nov 2022
MonColor
Metrovision
·
,
FR
Class IIa
CE/MDR
BE26/00000270
Active
Valid to Sep 2031
Spiegel-Exophthalmometer nach Naugle
OCULUS Optikgeräte GmbH
·
,
DE
Class I
CE/MDR
GUDID
on market
Previous
Next