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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

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

04260098593167

Polaskop2

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Deutsche Augenoptik GmbH
Manufacturer SRN: DE-MF-000007188
UDI-DI: 04260098593167
Basic UDI-DI: 426009859PS2J8
Reference: 3330
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:30

Manufacturer products View details

VISUCORE 500 System

000000-2548-409

Class IIaMDR 2017/745On the market

Manufacturer: Carl Zeiss Vision GmbH
Manufacturer SRN: DE-PR-000040411
UDI-DI: 04250668607219
Basic UDI-DI: 42506686-B01-VCR500S-5K
Reference: 000000-2548-409
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 00:43

Manufacturer products View details

VISUREF 600

000000-2572-424

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Carl Zeiss Vision GmbH
Manufacturer SRN: DE-MF-000006173
UDI-DI: 04250668607202
Basic UDI-DI: 42506686-B01-VR600-87
Reference: 000000-2572-424
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:43

Manufacturer products View details

VISUCORE 500 Refractor

000000-2522-537

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Carl Zeiss Vision GmbH
Manufacturer SRN: DE-MF-000006173
UDI-DI: 04250668606052
Basic UDI-DI: 42506686-B01-VCR500R-5G
Reference: 000000-2522-537
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:43

Manufacturer products View details

iOCT Module

V12400-01

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Munich Surgical Imaging GmbH
Manufacturer SRN: DE-MF-000009644
UDI-DI: 04064434000179
Basic UDI-DI: 4064434SeeLumaiOCTBT
Reference: V12400-01
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

04063058230313

Opthalmoskop / Ophthalmoscope

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: REDA Instrumente GmbH
Manufacturer SRN: DE-MF-000005592
UDI-DI: 04063058230313
Basic UDI-DI: 4063058000000833Z
Reference: RD-1912
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:15

Manufacturer products View details

ATLAS 500

for instrument table, for ophthalmic unit

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471098013
Basic UDI-DI: 4049471_CT00001_XH
Reference: 000000-2426-674, 000000-2472-389
EMDN: Z12120123
EMDN description: COMPUTERISED CORNEAL TOPOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:01

Manufacturer products View details

EUROLIGHT E10, 2.5V ophthalmoscope with srew thread

Ophthalmoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: Kirchner & Wilhelm GmbH + Co KG
Manufacturer SRN: DE-MF-000006338
UDI-DI: 04030155000385
Basic UDI-DI: 4030155KaWe0102YT
Reference: 01.21100.001
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 22:10

Manufacturer products View details