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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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Ophthalmometers
Ophthalmometers
Z12120113
32 devices
Devices
Auto Refractometer ACCUREF R-800
Rexxam Co., Ltd. Kagawa Factory
·
,
JP
Class I
CE/MDD
Auto Ref/Keratometer
Huvitz Co., Ltd.
·
,
KR
Class I
CE/MDR
GUDID
on market
Auto Ref/Keratometer
Huvitz Co., Ltd.
·
,
KR
Class I
CE/MDR
GUDID
on market
Fundus Camera SK-650B
Chongqing Sunkingdom Medical Instrument Co., Ltd
·
,
CN
Class I
CE/MDR
Optical Coherence Tomography OCT-R1
Canon Inc.
·
,
JP
Class IIa
CE/MDR
Optical Coherence Tomography OCT-S1
Canon Inc.
·
,
JP
Class IIa
CE/MDR
Auto Ref-Keratometer ACCUREF K-900
Rexxam Co., Ltd. Kagawa Factory
·
,
JP
Class I
CE/MDD
Akr 550
Essilor International
·
,
FR
Class I
CE/MDR
View-M
View-M Technology
·
,
KR
Class I
CE/MDD
Auto Ref/Keratometer
Huvitz Co., Ltd.
·
,
KR
Class I
CE/MDR
GUDID
on market
Ref Topo Ret-700
Rexxam Co., Ltd. Kagawa Factory
·
,
JP
Class I
CE/MDD
Akr 800
Essilor International
·
,
FR
Class I
CE/MDR
Natural Vision Auto Refkeratometer Nvision-K5001
Rexxam Co., Ltd. Kagawa Factory
·
,
JP
Class I
CE/MDD
Fundus Camera SK-660A
Chongqing Sunkingdom Medical Instrument Co., Ltd
·
,
CN
Class I
CE/MDR
Rebound Tonometer
Tianjin Suowei Electronic Technology Co., Ltd
·
,
CN
Class IIa
CE/MDR
Fundus Camera SK-650A
Chongqing Sunkingdom Medical Instrument Co., Ltd
·
,
CN
Class I
CE/MDR
Auto Ref/Keratometer
Huvitz Co., Ltd.
·
,
KR
Class I
CE/MDR
GUDID
on market
Auto Ref/Keratometer
Huvitz Co., Ltd.
·
,
KR
Class I
CE/MDR
GUDID
on market
Lens Reviewer
AkknaTek
·
,
DE
Class I
CE/MDD
Optical Coherence Tomography OCT-A1
Canon Inc.
·
,
JP
Class IIa
FDA 510(k)
K182942
Active
Cleared 24 Jul 2019
CE/MDR
+1
authorizations
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