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Applanation Tonometer SL-TM

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: Ohira Co.,Ltd.
Manufacturer SRN: JP-MF-000004195
UDI-DI: 04571260230705
Basic UDI-DI: 4571260230038S
Reference: B-45
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Italy
Authorised representative: Rexxam Co., Ltd. Netherlands Office
Last updated: 31.07.2026 06:02

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LED Slit Lamp XL-1

LED Slit Lamp

Class IMDR 2017/745On the marketActive device

Manufacturer: Ohira Co.,Ltd.
Manufacturer SRN: JP-MF-000004195
UDI-DI: 04571260230514
Basic UDI-DI: 4571260230028Q
Reference: XL-1
EMDN: Z12120108
EMDN description: SLIT LAMPS
First on market country: Italy
Authorised representative: Rexxam Co., Ltd. Netherlands Office
Last updated: 31.07.2026 06:02

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04571209675703

MC486 FULL RIM, MC674 FULL RIM, 580Univ Pro FULL RIM

Class IMDR 2017/745On the market

Manufacturer: Hasegawa Bicoh co.,ltd.
Manufacturer SRN: JP-MF-000029853
UDI-DI: 04571209675703
Basic UDI-DI: 457120967TrialFrameXT
Reference: MC486 FULL RIM
EMDN: Z12129099
EMDN description: VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 06:01

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SPECULAR MICROSCOPE SP-1P

SPECULAR MICROSCOPE

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130283466
Basic UDI-DI: 4560126260070UC
Reference: SP-1P
EMDN: Z12120110
EMDN description: CORNEAL CONFOCAL MICROSCOPES
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 06:01

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ANTERIOR SEGMENT ATTACHMENT KIT AA-1

Optional Accessories for TOPCON 3D Optical Coherent Tomography

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130282193
Basic UDI-DI: 4560126260041U5
Reference: AA-1
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 06:01

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ICG FILTER ATTACHMENT IF-1 for TRC-50DX

Optional Accessories for TOPCON Retinal Cameras

Class IMDR 2017/745On the market

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04562123289893
Basic UDI-DI: 4560126260021TX
Reference: IF-1
EMDN: Z12120105
EMDN description: FLUOROANGIOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 06:00

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CHINREST SO-CR03BF

Optional Accessories for TOPCON SLIT LAMPS

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04562123289794
Basic UDI-DI: 4560126260101TW
Reference: CHINREST SO-CR03BF
EMDN: Z12120108
EMDN description: SLIT LAMPS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 06:00

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AUTO CHART PROJECTOR ACP-8(Type: EM)

AUTO CHART PROJECTOR / PIXCEL CHART

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04562123289404
Basic UDI-DI: 4560126260120U2
Reference: ACP-8
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 06:00

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SLIT LAMP SL-2G

SLIT LAMP

Class IMDR 2017/745Not intended for EU marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126269225
Basic UDI-DI: 4560126260100TU
Reference: SLIT LAMP SL-2G for India
EMDN: Z12120108
EMDN description: SLIT LAMPS
First on market country: -
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

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AUTO REFRACTOMETER RM-800

AUTO REFRACTOMETER

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126269164
Basic UDI-DI: 4560126260050U6
Reference: RM-800
EMDN: Z12120115
EMDN description: OPTOMETERS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 31.07.2026 05:58

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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

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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

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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

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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

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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

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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

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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

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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

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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