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Active filter:EMDN:Z12120192

29 device results listed.

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07640486840856

Class IIaNot specifiedNo longer on the market

Manufacturer: Ikerian AG
Manufacturer SRN: CH-MF-000014537
UDI-DI: 07640486840856
Basic UDI-DI: 764048684Discovery18091G4
Reference: 07640486840856
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Blue Broccoli GmbH
Last updated: 31.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Retinai Layer Segmentation

RetinAI Layer Segmentation

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ikerian AG
Manufacturer SRN: CH-MF-000014537
UDI-DI: 07640486840023
Basic UDI-DI: 764048684Layer200412M
Reference: 7640486840023
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Blue Broccoli GmbH
Last updated: 31.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

07640486840016

RetinAI Fluid Segmentation

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ikerian AG
Manufacturer SRN: CH-MF-000014537
UDI-DI: 07640486840016
Basic UDI-DI: 764048684Fluid20042X5
Reference: 7640486840016
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Blue Broccoli GmbH
Last updated: 31.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Image Filing Software NAVIS-EX

NAVIS-EX

Class IIaMDR 2017/745On the marketActive device

Manufacturer: NIDEK.CO.Ltd.,
Manufacturer SRN: JP-MF-000040151
UDI-DI: 04987669101643
Basic UDI-DI: 4987669217GH
Reference: 19702-0040
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: NIDEK SA
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Retinai Discovery

RetinAI Discovery

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Ikerian AG
Manufacturer SRN: CH-MF-000014537
UDI-DI: 07640486840047
Basic UDI-DI: 764048684Discovery18091G4
Reference: 7640486840047
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Blue Broccoli GmbH
Last updated: 22.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

OPHTHALMIC DATA SYSTEM IMAGEnet 6

IMAGEnet 6

Class IMDDOn the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: D-JPMF3928_1036133-01UL
Basic UDI-DI: B-JPMF3928_1036133-01UL
Reference: 1036133-01
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: 17.07.2026 05:07

Manufacturer products Authorised representative products Authorised representative actors View details

Assure Plus

Assure Plus 1.0.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Eyetelligence Pty Ltd, an Optain Health Company
Manufacturer SRN: AU-MF-000044109
UDI-DI: 00860011973201
Basic UDI-DI: 08600119732APVN
Reference: Assure Plus 1.0.0
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-ITOS-standaloneXB

ITOS standalone

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Voigtmann GmbH
Manufacturer SRN: DE-MF-000013049
UDI-DI: D-ITOS-standaloneXB
Basic UDI-DI: B-ITOS-standaloneXB
Reference: ITOS standalone
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 02:16

Manufacturer products View details

EyeArt

2.1.0

Class IIaMDDOn the marketActive device

Manufacturer: Eyenuk, Inc.
Manufacturer SRN: US-MF-000004180
UDI-DI: 00860000470018
Basic UDI-DI: B-00860000470018
Reference: 2.1.0
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:44

Manufacturer products Authorised representative products Authorised representative actors View details

M&S Technologies Smart System® Virtual Reality Headset System

VR-1002H

Class IMDDOn the marketActive device

Manufacturer: M&S Technologies
Manufacturer SRN: US-MF-000048924
UDI-DI: 00850040295122
Basic UDI-DI: B-00850040295122
Reference: VR-1002H
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Certification Company
Last updated: 05.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

08800045800076

VN-M-03

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800076
Basic UDI-DI: 88000458VFSZ7
Reference: VN-M-03
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

easee online eye exam

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: easee b.v.
Manufacturer SRN: NL-MF-000021408
UDI-DI: 08720299818118
Basic UDI-DI: 87202998181EASEEEYEEXAMZ8
Reference: eo-018
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:53

Manufacturer products View details

RS Plus

RSPlus

Class IMDR 2017/745On the market

Manufacturer: IDCP Solutions BV
Manufacturer SRN: NL-MF-000038184
UDI-DI: 08719333039381
Basic UDI-DI: 871933303938RSPLus01EQ
Reference: RS Plus
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:37

Manufacturer products View details

Retinow

RAI01

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Retinow Sağlık Teknolojileri ve ARGE Sanayi Anonim Şirketi
Manufacturer SRN: TR-MF-000035284
UDI-DI: 08683845754011
Basic UDI-DI: 8683845754RAI01KF
Reference: RAI01-V01
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:16

Manufacturer products View details

UMI DR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: ULMA Medical Technologies, S.L.U.
Manufacturer SRN: ES-MF-000019352
UDI-DI: 08437024282013
Basic UDI-DI: 8437024282ULMASWIAOFT016K
Reference: 08437024282013
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:13

Manufacturer products View details

Ophthal

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: MR DOC S.R.L.
Manufacturer SRN: IT-MF-000027809
UDI-DI: 08053610750003
Basic UDI-DI: 805361075OPHJW
Reference: OPH_IT
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:49

Manufacturer products View details

LuxIA

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Ikerian AG
Manufacturer SRN: CH-MF-000014537
UDI-DI: 07640486841211
Basic UDI-DI: 764048684Luxia20101BE
Reference: 7640486841211
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Blue Broccoli GmbH
Last updated: 03.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

RetinAI Macula Biomarkers

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Ikerian AG
Manufacturer SRN: CH-MF-000014537
UDI-DI: 07640486841167
Basic UDI-DI: 764048684Biomarker20043SV
Reference: 7640486841167
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Blue Broccoli GmbH
Last updated: 03.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details