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461 device results listed.

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ARKM-200

Class IIaMDDNo longer on the marketActive deviceMeasuring function

Manufacturer: Takagi seiko
Manufacturer SRN: JP-MF-000008791
UDI-DI: 04560323644665
Basic UDI-DI: B-04560323644665
Reference: B06002
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.08.2026 10:49

Manufacturer products Authorised representative products Authorised representative actors View details

Fundus Viewing System

600B

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Shanghai Mediworks Precision Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000004251
UDI-DI: 06945087500286
Basic UDI-DI: 69450875600BLE
Reference: 600B
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

Stereoptic Inverter

600A

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Shanghai Mediworks Precision Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000004251
UDI-DI: 06945087500279
Basic UDI-DI: 69450875600ALC
Reference: 600A
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

Lumio

003

Class IMDR 2017/745On the marketActive device

Manufacturer: Aston Vision Sciences Ltd.
Manufacturer SRN: UK-MF-000038786
UDI-DI: 05070002498346
Basic UDI-DI: 50700024983003DX
Reference: 003
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Ireland
Authorised representative: Eclipse Medtech Ltd
Last updated: 31.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Amsler Chart (Pad of 50)

Amsler Grid

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Keeler Ltd
Manufacturer SRN: GB-MF-000009031
UDI-DI: 05055272706773
Basic UDI-DI: 50552727AmslerGridH7
Reference: 2215-P-7057
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: Keeler Europe Distribution, S.L.
Last updated: 31.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

Peter Rabbit Test

Vision testing/training chart

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Keeler Ltd
Manufacturer SRN: GB-MF-000009031
UDI-DI: 05055272720885
Basic UDI-DI: 50552727VisionTestChartA3
Reference: 2205-L-1004
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Greece
Authorised representative: Keeler Europe Distribution, S.L.
Last updated: 31.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

POCKET SET 2.8V

Ophthalmic/otologic diagnostic set

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Keeler Ltd
Manufacturer SRN: GB-MF-000009031
UDI-DI: 05055272700641
Basic UDI-DI: 5055272745084XR
Reference: 1102-P-1041
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: Keeler Europe Distribution, S.L.
Last updated: 31.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III

OPD-Scan III

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NIDEK.CO.Ltd.,
Manufacturer SRN: JP-MF-000040151
UDI-DI: 04987669100776
Basic UDI-DI: 4987669208GG
Reference: B01E009
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Northern Ireland
Authorised representative: NIDEK SA
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Non-Mydriatic Auto Fundus Camera AFC-330

AFC-330

Class IIaMDR 2017/745On the marketActive device

Manufacturer: NIDEK.CO.Ltd.,
Manufacturer SRN: JP-MF-000040151
UDI-DI: 04987669100554
Basic UDI-DI: 4987669213G9
Reference: 15411-0E00,15411-00B0
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: France
Authorised representative: NIDEK SA
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

SPECULAR MICROSCOPE CEM-530

CEM-530

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NIDEK.CO.Ltd.,
Manufacturer SRN: JP-MF-000040151
UDI-DI: 04987669100530
Basic UDI-DI: 4987669211G5
Reference: B01E008
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: NIDEK SA
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Optical Coherence Tomography RS-3000 Advance

RS-1,Mirante,RS-3000 Advance

Class IIaMDR 2017/745On the marketActive device

Manufacturer: NIDEK.CO.Ltd.,
Manufacturer SRN: JP-MF-000040151
UDI-DI: 04987669100516
Basic UDI-DI: 4987669216GF
Reference: 10703-0050, 10703-02B0
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: NIDEK SA
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DSC series

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872710066
Basic UDI-DI: 47198727100007L
Reference: MiiS Horus Scope DSC 300
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:01

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DEA 100, DGC 200

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872711056
Basic UDI-DI: 47198727110027X
Reference: MiiS Horus+ Scope DGC 200
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DEC series, EEC series

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872711032
Basic UDI-DI: 47198727110007T
Reference: MiiS Horus Scope EEC 100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DSC series

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872710028
Basic UDI-DI: 47198727100007L
Reference: MiiS Horus+ Scope DSC 200
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DEA 100, DGC 200

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872711025
Basic UDI-DI: 47198727110027X
Reference: MiiS Horus Scope DEA 100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DEC series, EEC series

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872711018
Basic UDI-DI: 47198727110007T
Reference: MiiS Horus Scope DEC 100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors 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