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OPHTHALMIC DATA SYSTEM IMAGEnet 7

OPHTHALMIC DATA SYSTEM

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268976
Basic UDI-DI: 4560126260080UF
Reference: IMAGEnet 7
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

AUTO KERATO-REFRACTO TONOMETER

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268860
Basic UDI-DI: 4560126260010TS
Reference: TRK-3 OMNIA
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

04560126268563

Optional Accessory for COMPU VISION CV-5000

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268563
Basic UDI-DI: 4560126260111TZ
Reference: 1 DIAL CONTROLLER KB-50S
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

COMPU VISION CV-5000

COMPU VISION / VISION TESTER

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268518
Basic UDI-DI: 4560126260110TX
Reference: CV-5000
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

REFRACTION SYSTEM Chronos

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-PR-000041957
UDI-DI: 04560126268341
Basic UDI-DI: 4560126260500UG
Reference: Chronos
EMDN: Z12120115
EMDN description: OPTOMETERS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:58

Manufacturer products View details

3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton2

3D Optical Coherence Tomography

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268303
Basic UDI-DI: 4560126260040U3
Reference: DRI OCT Triton2
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

NON-MYDRIATIC RETINAL CAMERA NW500

RETINAL CAMERA

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268204
Basic UDI-DI: 4560126260020TV
Reference: NW500
EMDN: Z12120105
EMDN description: FLUOROANGIOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Chinrest CRX-1000 for REFRACTION SYSTEM Chronos

Optional Accessories for REFRACTION SYSTEM Chronos

Class IMDR 2017/745On the market

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268198
Basic UDI-DI: 4560126260061UB
Reference: CRX-1000
EMDN: Z12120115
EMDN description: OPTOMETERS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

REFRACTION SYSTEM Chronos

AUTO KERATO-REFRACTOMETER

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268174
Basic UDI-DI: 4560126260060U9
Reference: Chronos
EMDN: Z12120115
EMDN description: OPTOMETERS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

COMPUTERIZED TONOMETER　CT-800

COMPUTERIZED TONOMETER

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268150
Basic UDI-DI: 4560126260030TY
Reference: CT-800
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Retinal Camera CR-10

Digital Retinal Camera

Class IMDR 2017/745On the marketActive device

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292228489
Basic UDI-DI: 4549292rc01DK
Reference: BT8-2172
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Netherlands
Authorised representative: Canon Medical Systems Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Full Auto Ref-Keratometer RK-F3m

Full Auto Ref-Keratometer

Class IIaMDR 2017/745On the market

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292214802
Basic UDI-DI: 4549292rk01ET
Reference: RB-A20A-B009
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Netherlands
Authorised representative: Canon Medical Systems Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Optical Coherence Tomography OCT-A1

Optical Coherence Tomography

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292147216
Basic UDI-DI: 4549292oc01CW
Reference: BT8-1835
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Netherlands
Authorised representative: Canon Medical Systems Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Ophthalmic Software Platform RX(RX Capture for Retinal Camera, RX Server, RX Viewer)

Ophthalmic Software Platform

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292084696
Basic UDI-DI: 4549292es01D8
Reference: BT8-1836
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Canon Medical Systems Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Full Auto Tonometer TX-20P

Full Auto Tonometer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292074376
Basic UDI-DI: 4549292to01FV
Reference: BT8-2590
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Netherlands
Authorised representative: Canon Medical Systems Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

SLIT LAMP RS-5000

RS-5000

Class IMDR 2017/745On the marketActive device

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008310627
Basic UDI-DI: 45400080000837
Reference: RS303
EMDN: Z12120108
EMDN description: SLIT LAMPS
First on market country: Italy
Authorised representative: Rexxam Co., Ltd. Netherlands Office
Last updated: 31.07.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

PASKAL 3D

5.0

Class IMDR 2017/745On the marketDirect marking

Manufacturer: EVEX Deutschland GmbH
Manufacturer SRN: DE-MF-000037933
UDI-DI: 04262451050003
Basic UDI-DI: 426245105PasKalSD
Reference: PASKAL 3D
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:37

Manufacturer products View details

Merlin

Typ2102

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zeisberg GmbH
Manufacturer SRN: DE-MF-000024273
UDI-DI: 04262388710247
Basic UDI-DI: 426238871T21023K
Reference: FP30.AR01
EMDN: Z12120124
EMDN description: VIDEO/ELECTRONYSTAGMOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:24

Manufacturer products View details

wall diagnostic center with otoscope and ophthalmoscope

wall diagnostic center

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Luxamed GmbH & Co. KG
Manufacturer SRN: DE-MF-000006437
UDI-DI: 04260381965008
Basic UDI-DI: 426038196WandstationSC
Reference: W1.336.114
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:57

Manufacturer products View details

LuxaScope Oculus

LuxaScope Oculus LED

Class IMDR 2017/745On the marketActive device

Manufacturer: Luxamed GmbH & Co. KG
Manufacturer SRN: DE-MF-000006437
UDI-DI: 04260381964315
Basic UDI-DI: 426038196OphthalmoskopZH
Reference: F1.416.114
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:54

Manufacturer products View details