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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
577nm LIO
Keeler Ltd
·
,
United Kingdom
Class IIb
CE/MDD
GUDID
on market
Trial Lenses
Nelthema srls
·
,
Italy
Class I
CE/MDR
Offset Strut Table
Evans (Instruments) Ltd
·
,
United Kingdom
Class I
CE/MDR
Schermo Di Hess- 50°
C.O.I. Compagnia Ottica Italiana srl
·
,
Italy
Class I
CE/MDR
Slimline 3.6V Practitioner/Fibre-Optic Diagnostic Set
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
3.6V Professional Student Set
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
3.6V Streak Ret & Professional Ophth With 2 Handles
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
Kay Pictures Ltd
Kay Pictures
·
,
United Kingdom
Class I
CE/MDR
Headlight Loupes
Visuscience Meditech Co., Ltd.
·
,
China
Class I
CE/MDR
Osa
Sbm Sistemi SRL
·
,
Italy
Class I
CE/MDR
GUDID
on market
3.6V Student Set Cw
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
Polarized Wrap-Around Glasses, Adult
Gulden Ophthalmics
·
,
United States
Class I
CE/MDR
3.6V Streak/Professional Student Set (Essilor)
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
Visuref 600
Carl Zeiss Vision GmbH
·
,
Germany
Class IIa
CE/MDR
1000266776
Expired
Valid to Oct 2026
FDA 510(k)
K253834
Active
Cleared 18 Mar 2026
+1
authorizations
Dino-Lite
Idcp BV
·
,
Netherlands
Class I
CE/MDR
Gaush Idea
Sbm Sistemi SRL
·
,
Italy
Class I
CE/MDR
Red & Green Wrap-Around Glasses, Child
Gulden Ophthalmics
·
,
United States
Class I
CE/MDR
3.6V Standard Diagnostic Set
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
3.6V Practitioner Led Ophth / Oto Diagnostic Set
Keeler Ltd
·
,
United Kingdom
Class I
CE/MDR
Reversed Red & Green Wrap-Around Glasses, Adult
Gulden Ophthalmics
·
,
United States
Class I
CE/MDR
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