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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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Ophtalmology assessments and diagnosis instruments – other
Ophtalmology assessments and diagnosis instruments – other
Z12120199
405 devices
Devices
Operating Microscope
Shenzhen Certainn Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Lumio
Aston Vision Sciences Ltd.
·
,
GB
Class I
CE/MDR
Eidon Fa
Centervue S.P.A.
·
,
IT
Class IIa
CE/MDD
FDA 510(k)
K180526
Active
Cleared 16 Jul 2018
+2
authorizations
ARC 514/810nm
Keeler Ltd
·
,
GB
Class IIb
CE/MDD
Microclear
Suzhou Microclear Medical Instruments Co., Ltd.
·
,
CN
Class IIa
CE/MDR
CN25/00003315
Active
Valid to May 2030
CE/MDD
Precisio
iVis Technologies S.r.l.
·
,
IT
Class IIb
CE/MDR
OMA (810 nm)
Iridex Corporation
·
,
US
Class I
CE/MDR
GUDID
on market
Multiple Pinhole Occluder Short
Gulden Ophthalmics
·
,
US
Class I
CE/MDR
Set 21 Prismi Quadrati
C.O.I. Compagnia Ottica Italiana srl
·
,
IT
Class I
CE/MDR
Kay Pictures Ltd
Kay Pictures
·
,
GB
Class I
CE/MDR
Kay Pictures Ltd
Kay Pictures
·
,
GB
Class I
CE/MDR
Evans Near Vision Unit/Norwegian
Evans (Instruments) Ltd
·
,
GB
Class I
CE/MDR
Tfa
Sbm Sistemi SRL
·
,
IT
Class I
CE/MDR
DSLC200
Sbm Sistemi SRL
·
,
IT
Class I
CE/MDR
Microclear
Suzhou Microclear Medical Instruments Co., Ltd.
·
,
CN
Class IIa
CE/MDR
CN25/00003315
Active
Valid to May 2030
Tfa-2
Sbm Sistemi SRL
·
,
IT
Class I
CE/MDR
3.6V Practitioner/Fibre-Optic Desk Set
Keeler Ltd
·
,
GB
Class I
CE/MDR
Cache œil
Comed SAS
·
,
FR
Class I
CE/MDR
Sting-Ray Table Base
Evans (Instruments) Ltd
·
,
GB
Class I
CE/MDR
Slimline 2.8V Spot Ret & Specialist Ophth
Keeler Ltd
·
,
GB
Class I
CE/MDR
GUDID
on market
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