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08809240011300

PLC-8000, PLC-8000pola, TCP-4000, TCP-4000P, CV 600, CV 800P, PLC-9000, PLC-9000pola

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: POTEC Co., Ltd.
Manufacturer SRN: KR-MF-000012281
UDI-DI: 08809240011300
Basic UDI-DI: 88092400113SP
Reference: PLC-8000pola
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

HUVITZ

HVF-100

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Huvitz Co., Ltd.
Manufacturer SRN: KR-MF-000015802
UDI-DI: 08800019600824
Basic UDI-DI: 88000196VF001FS
Reference: CTXXCL-22-00001
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

08800019600190

HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Huvitz Co., Ltd.
Manufacturer SRN: KR-MF-000015802
UDI-DI: 08800019600190
Basic UDI-DI: 88000196DC0018X
Reference: C3ARAA-16-00001
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:17

Manufacturer products Authorised representative products Authorised representative actors View details

08720892364715

SONDA Hub

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Reyedar B.V.
Manufacturer SRN: NL-MF-000040158
UDI-DI: 08720892364715
Basic UDI-DI: 87208923647HUB8K
Reference: SONDA Hub
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:08

Manufacturer products View details

Waggoner Diagnostics

Waggoner-CCVT

Class IMDR 2017/745On the market

Manufacturer: Waggoner Diagnostics
Manufacturer SRN: US-MF-000011157
UDI-DI: 00860007023408
Basic UDI-DI: 8600070234087L
Reference: Waggoner-CCVT
EMDN: Z1212012092
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: E C REP LIMITED
Last updated: 03.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

OptoSense Spectra

Spectra

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXACorteX s.r.o.
Manufacturer SRN: CZ-MF-000053063
UDI-DI: 08594235000000
Basic UDI-DI: 859423500OptoSpecXC
Reference: OS-SPECTRA-001
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:53

Manufacturer products View details

MojeOči

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Apollo Data s.r.o.
Manufacturer SRN: CZ-MF-000050791
UDI-DI: 08594232160011
Basic UDI-DI: 859423216001GS
Reference: 08594232160011
EMDN: Z1212012092
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:53

Manufacturer products View details

ViFiA

Class IMDR 2017/745On the marketActive device

Manufacturer: Tindaya s.r.o.
Manufacturer SRN: CZ-MF-000051158
UDI-DI: 08594231440039
Basic UDI-DI: 859423144ViFiAVC
Reference: N/A
EMDN: Z1212012092
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:53

Manufacturer products View details

DIVE Automatic visual exam and screening

DIVE Device for automatic visual exam and screening

Class IIaMDR 2017/745No longer on the marketActive deviceDirect markingMeasuring function

Manufacturer: DIVE MEDICAL S.L
Manufacturer SRN: ES-MF-000001070
UDI-DI: 8437021711011
Basic UDI-DI: 8437021711004DIVE01WF
Reference: DIVE Device for automatic visual exam and screening
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:18

Manufacturer products View details

Pantalla Tangente

XR1

Class IMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: General ASDE, S.A.
Manufacturer SRN: ES-MF-000014654
UDI-DI: 08437024525042
Basic UDI-DI: 8437024525campH5
Reference: PT XR1
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:14

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Juego Anáglifos VERTICAL - Fijo

Material de Entrenamiento Visual-Vectogramas Anáglifos

Class IMDR 2017/745On the market

Manufacturer: PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L.
Manufacturer SRN: ES-MF-000055881
UDI-DI: 08436633521001
Basic UDI-DI: 843663352MEV-VAGT
Reference: 9517
EMDN: Z1212012080
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:01

Manufacturer products View details

Tests de Visión Próxima (40 cm)

Exploración Función Visual

Class IMDR 2017/745On the market

Manufacturer: PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L.
Manufacturer SRN: ES-MF-000055881
UDI-DI: 08436633520257
Basic UDI-DI: 843663352ExFVPP
Reference: 9902
EMDN: Z1212012080
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:01

Manufacturer products View details

Separador Blanco (Septum)

Material de Entrenamiento Visual

Class IMDR 2017/745On the market

Manufacturer: PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L.
Manufacturer SRN: ES-MF-000055881
UDI-DI: 08436633520080
Basic UDI-DI: 843663352MEVPL
Reference: 9535
EMDN: Z1212012080
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:01

Manufacturer products View details

Oclusor Negro

Exploración Función Visual - Accesorio

Class IMDR 2017/745On the market

Manufacturer: PROMOCIÓN OPTOMÉTRICA DE BURGOS, S.L.
Manufacturer SRN: ES-MF-000055881
UDI-DI: 08436633520004
Basic UDI-DI: 843663352ExFVAPQ
Reference: 9756-C
EMDN: Z1212012080
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:01

Manufacturer products View details

NOC-8

NOC

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: EYENEXT SRL
Manufacturer SRN: IT-MF-000052290
UDI-DI: 08058045451266
Basic UDI-DI: 805804545NAG
Reference: NOC
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:53

Manufacturer products View details

AOC-24 Pola

AOC

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: EYENEXT SRL
Manufacturer SRN: IT-MF-000052290
UDI-DI: 08058045450016
Basic UDI-DI: 805804545AOCJX
Reference: AOC-24 Pola
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:53

Manufacturer products View details

EYETABLET

Class IMDR 2017/745On the marketDirect marking

Manufacturer: DMD Computers s.r.l.
Manufacturer SRN: IT-MF-000044809
UDI-DI: 08056157470021
Basic UDI-DI: 805615747DMDEYETABLA7
Reference: 4DMD EYETABL-3W
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:05

Manufacturer products View details

FVD24

Visual Chart Panel

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DMD Computers s.r.l.
Manufacturer SRN: IT-MF-000044809
UDI-DI: 08056157470007
Basic UDI-DI: 805615747DMDFVD24WS
Reference: 4DMD FVD-24
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:05

Manufacturer products View details

OPTINET

Class IMDR 2017/745On the marketActive device

Manufacturer: Tesi Elettronica e Sistemi Informativi S.p.A.
Manufacturer SRN: IT-MF-000021278
UDI-DI: 08055774030038
Basic UDI-DI: 805577403OPTINET2M
Reference: OPTINET
EMDN: Z1212012082
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 10:54

Manufacturer products View details

iCare MAIA

MAIA

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CENTERVUE S.P.A.
Manufacturer SRN: IT-MF-000017082
UDI-DI: 08053677040130
Basic UDI-DI: 805367704MicroPerimeterRM
Reference: AHMACME001
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:49

Manufacturer products View details