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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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Optical consistency tomographs
Optical consistency tomographs
Z12120121
61 devices
Ophthalmic Optical Coherence Tomography System
Guangdong Weiren Meditech Co., Ltd
·
,
China
Class IIa
CE/MDR
SPECTRALIS Platform
Heidelberg Engineering GmbH
·
,
Germany
Class IIa
CE/MDR
3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus)
Topcon Corporation
·
,
Japan
Class IIa
CE/MDD
Spectral Optical Coherence Tomographer REVO 60
Optopol Technology Sp Z O O
·
,
Poland
Class IIa
CE/MDR
Ophthalmic Optical Coherence Tomography Systems
TowardPi (Shanghai) Medical Technology Ltd.
·
,
China
Class IIa
CE/MDR
DRI OCT Triton (plus)
Topcon Corporation
·
,
Japan
Class IIa
CE/MDR
Dream Oct
Intalight Group Co., Ltd.
·
,
China
Class IIa
CE/MDR
Galilei G4
SIS Ltd., Surgical Instrument System
·
,
Switzerland
Class IIa
CE/MDR
GUDID
on market
Optical Coherence Tomography RS-3000 Advance
Nidek Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
4202074CE01
Expiring
Valid to Nov 2026
FDA 510(k)
×2
K121622
Active
+1
authorizations
Scanning Laser Ophthalmoscope Mirante
Nidek Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
4202074CE01
Expiring
Valid to Nov 2026
GUDID
on market
Optical Coherence Tomography RS-1
Nidek Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
4202074CE01
Expiring
Valid to Nov 2026
Optical Coherence Tomography RS-330
Nidek Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
4202074CE01
Expiring
Valid to Nov 2026
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