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COMPASS

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CENTERVUE S.P.A.
Manufacturer SRN: IT-MF-000017082
UDI-DI: 08053677040048
Basic UDI-DI: 805367704PerimeterV7
Reference: AMGSDME001
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

HENSON 9000

Class IMDR 2017/745On the marketActive device

Manufacturer: Visia imaging SRL
Manufacturer SRN: IT-MF-000015628
UDI-DI: 08034028770418
Basic UDI-DI: 803402877PERIMETER1DM
Reference: HENSON9000
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

TEST GIMA DI PERCEZIONE DEL COLORE - 10 tavole - pediatrico

Test visivi e oculistici

Class IMDR 2017/745On the market

Manufacturer: GIMA SPA
Manufacturer SRN: IT-MF-000011004
UDI-DI: 08023279312867
Basic UDI-DI: 8023279Z121201990000000YY
Reference: 31286
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:34

Manufacturer products View details

VisionOne VFT

Class IIaMDR 2017/745On the marketActive device

Manufacturer: PeriVision SA
Manufacturer SRN: CH-MF-000047664
UDI-DI: 07649990085098
Basic UDI-DI: 7649990085VO.004NG
Reference: VO.004
EMDN: Z1212012092
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: International Associates Auditing & Certification Limited
Last updated: 03.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors 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

VisionOne

Perimetry device

Class IIaMDR 2017/745No longer on the marketActive deviceMeasuring function

Manufacturer: Effectum Medical AG
Manufacturer SRN: CH-MF-000012474
UDI-DI: 07640255020663
Basic UDI-DI: 764025502TD01648
Reference: 016.001.001, 016.001.002
EMDN: Z1212012092
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

Phoropter Refractor 900

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Haag-Streit AG
Manufacturer SRN: CH-MF-000020981
UDI-DI: 07640132988871
Basic UDI-DI: 764013298Refraktor90068
Reference: 1420241
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Germany
Authorised representative: Haag-Streit Deutschland GmbH
Last updated: 03.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

KMScreen DICOM SOFTWARE PLUS

KMScreen SDL FULL

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ORTHO KM
Manufacturer SRN: SE-MF-000044308
UDI-DI: 73501152025720
Basic UDI-DI: 7350115200431S2
Reference: KMScreen DICOM SOFTWARE PLUS
EMDN: Z1212012004
EMDN description: HESS SCREENS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

External Telescope Simulator

PR00107-00

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Samsara Vision Ltd.
Manufacturer SRN: IL-MF-000018630
UDI-DI: 07290018786055
Basic UDI-DI: 7290018786ETS2800107L9
Reference: PR00107-00
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

BOKE

BOKE-A001

Class IMDR 2017/745On the marketActive device

Manufacturer: Boke Medical Technology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000041742
UDI-DI: 06977282760011
Basic UDI-DI: 697728276BK24001GP
Reference: 001
EMDN: Z1212012082
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors 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

Automitic Perimeter SK-850A

SK-850A,SK-850AS,850AE,SK-950B,SK-950C

Class IMDR 2017/745On the marketActive device

Manufacturer: ChongQing SunKingdom Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000014351
UDI-DI: 06973211071166
Basic UDI-DI: 69732110701PE7Y
Reference: 04
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
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

Hess Screen

Class IMDR 2017/745On the market

Manufacturer: Evans (Instruments) Ltd
Manufacturer SRN: GB-MF-000007806
UDI-DI: 05060660330249
Basic UDI-DI: 506066033HS36398UL
Reference: 331
EMDN: Z1212012004
EMDN description: HESS SCREENS
First on market country: Ireland
Authorised representative: VeriSafe Compliance Limited
Last updated: 02.07.2026 02:30

Manufacturer products Authorised representative products Authorised representative actors View details