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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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Tonometers
Tonometers
Z12120122
107 devices
Devices
D-Kat R-Type (Disposable Prism)
Keeler Ltd
·
,
GB
Class IIa
CE/MDD
GUDID
on market
Applanation Tonometer SL-TM
Ohira Co., Ltd.
·
,
JP
Class I
CE/MDR
iCare HOME2
Icare Finland Oy
·
,
FI
Class IIa
CE/MDR
FI22/00000011
Active
Valid to Oct 2030
Applanation Tonometer AT 900 model BQ
Haag-Streit AG
·
,
CH
Class I
CE/MDD
GUDID
on market
Applanation Tonometer SL-TM
Ohira Co., Ltd.
·
,
JP
Class I
CE/MDR
Appasamy
Appasamy Associates Private Limited
·
,
IN
Class IIa
CE/MDR
Pulsair Intellipuff
Keeler Ltd
·
,
GB
Class IIa
CE/MDD
GUDID
on market
Applanation Tonometer
Shanghai Mediworks Precision Instruments Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Non Contact Tonometer Nt-1
Nidek Co., Ltd.
·
,
JP
Class IIa
CE/MDR
4202074CE01
Expiring
Valid to Nov 2026
Computerized Tonometer Ct-1
Topcon Corporation
·
,
JP
Class IIa
CE/MDD
D-Kat T-Type (Disposable Prism)
Keeler Ltd
·
,
GB
Class IIa
CE/MDD
GUDID
on market
iCare HOME2
Icare Finland Oy
·
,
FI
Class IIa
CE/MDR
FI22/00000011
Active
Valid to Oct 2030
FDA 510(k)
K211355
Active
Cleared 25 Jan 2022
Tonometer
ATCOR MEDICAL Pty Ltd
·
,
AU
Class IIa
CE/MDD
AccuPen
Accutome Inc. DBA Keeler USA
·
,
US
Class IIa
CE/MDD
GUDID
on market
D-KAT Z-Type
Keeler Ltd
·
,
GB
Class IIa
CE/MDD
GUDID
on market
Applanation Tonometer SL-TM
Ohira Co., Ltd.
·
,
JP
Class I
CE/MDR
Applanation Tonometer AT 900 model BQ
Haag-Streit AG
·
,
CH
Class I
CE/MDD
GUDID
on market
Applanation Tonometer AT 900 model R
Haag-Streit AG
·
,
CH
Class I
CE/MDD
GUDID
on market
iCare ST500
Icare Finland Oy
·
,
FI
Class IIa
CE/MDR
FI22/00000011
Active
Valid to Oct 2030
Non-contact tonometer with pachymeter
Crystalvue Medical Corporation
·
,
TW
Class IIa
CE/MDR
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