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184 device results listed.

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Raff Level Trial Flipper

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151560.
Basic UDI-DI: ++B091LensHoldersC6
Reference: 15156
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 05.07.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

08809240018842

PACP-8000, TCP-4042, Rodachart 422

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: POTEC Co., Ltd.
Manufacturer SRN: KR-MF-000012281
UDI-DI: 08809240018842
Basic UDI-DI: 88092400114SR
Reference: PACP-8000
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

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

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

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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

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

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

Manufacturer products View details

VisionOne System

Perimetry system

Class IIaMDR 2017/745No longer on the marketNo EU rep

Manufacturer: Effectum Medical AG
Manufacturer SRN: CH-PR-000043014
UDI-DI: 07640255020694
Basic UDI-DI: 764025502TD016S22
Reference: 016.001.005
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 06:43

Manufacturer products View details

Chart Projector

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TAIYUAN NORTH CHINA XINYUAN TECH CENTER (CO., LTD)
Manufacturer SRN: CN-MF-000031606
UDI-DI: 06975467343011
Basic UDI-DI: 697546734300NQ
Reference: CP-60
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 19:06

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Phoropter

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TAIYUAN NORTH CHINA XINYUAN TECH CENTER (CO., LTD)
Manufacturer SRN: CN-MF-000031606
UDI-DI: 06975467342014
Basic UDI-DI: 697546734200NK
Reference: AP-800
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 19:05

Manufacturer products Authorised representative products Authorised representative actors View details

Contrast Sensitivity Tester

RM800

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Wenzhou Gaush Raymond Photoelectric Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000022965
UDI-DI: 06974546310142
Basic UDI-DI: 6974546310004AK
Reference: RM800
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

Visual Function Tester

PAM-1

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Wenzhou Gaush Raymond Photoelectric Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000022965
UDI-DI: 06974546310012
Basic UDI-DI: 6974546310005AM
Reference: PAM1
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

Retinometer SK-6500A

Retinomter SK-6500A,SK-6500B

Class IMDR 2017/745On the marketActive device

Manufacturer: ChongQing SunKingdom Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000014351
UDI-DI: 06973211071340
Basic UDI-DI: 69732110709RE9E
Reference: 04
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 14:21

Manufacturer products Authorised representative products Authorised representative actors View details

06972413910044

SW-800

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable

Manufacturer: Tianjin Suowei Electronic Technology Co., Ltd
Manufacturer SRN: CN-MF-000030245
UDI-DI: 06972413910044
Basic UDI-DI: 697241391SW-800GB
Reference: SW-800
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

VISUAL FUNCTION ANALYSERS

YPB-2100

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000012019
UDI-DI: 06971922133081
Basic UDI-DI: 697192213300HR
Reference: YPB21/13
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

LCD Visual Chart

YPB-2100P

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable

Manufacturer: CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000012019
UDI-DI: 06971922133326
Basic UDI-DI: 697192213310HU
Reference: YPB21P/7
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

OFA

OFA-001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: KONAN MEDICAL USA, INC.
Manufacturer SRN: US-MF-000014687
UDI-DI: 04582275270075
Basic UDI-DI: 458227526KONAN-OPELW
Reference: PR-OFA-A
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 00:01

Manufacturer products Authorised representative products Authorised representative actors View details

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: 04562123289411
Basic UDI-DI: 4560126260120U2
Reference: ACP-8 (Type:EM)
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 01.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

MIRROR CHART MC-5S for CV-5000

Optional Accessory for COMPU VISION CV-5000

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126269300
Basic UDI-DI: 4560126260111TZ
Reference: MIRROR CHART MC-5S
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 01.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details