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FRONTIFOCOMETRO

Class IMDR 2017/745On the marketActive deviceContains latex

Manufacturer: Ellegi Medical Optics S.r.l.
Manufacturer SRN: IT-MF-000041265
UDI-DI: 08053608790004
Basic UDI-DI: 805360879LM-98083
Reference: LM-980
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:44

Manufacturer products View details

EASYTEAR® VIEW+

EASYTEAR® ALL in ONE

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: EASYTEAR SRL
Manufacturer SRN: IT-MF-000021630
UDI-DI: 08050999080028
Basic UDI-DI: 805099908ALLinONERD
Reference: 141001
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:50

Manufacturer products View details

CC-100 HW6.0

CC-100 HW6.0 / CC-100XP HW6.0

Class IMDR 2017/745On the marketActive device

Manufacturer: Visia imaging SRL
Manufacturer SRN: IT-MF-000015628
UDI-DI: 08034028770319
Basic UDI-DI: 803402877VISUALCHART1L6
Reference: 42-0000087
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

neos

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: machineMD AG
Manufacturer SRN: CH-MF-000041378
UDI-DI: 07649989541017
Basic UDI-DI: 7649989541-neos-0XX-F5
Reference: NEOS-01
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: MED-RAS GmbH Regulatory Affairs Service
Last updated: 03.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

BulbiCAM

Advanced Video-Oculography (VOG)

Class IIaMDR 2017/745On the marketActive deviceContains latexDirect marking

Manufacturer: Bulbitech AS
Manufacturer SRN: NO-MF-000040782
UDI-DI: 07090066420006
Basic UDI-DI: 709006642BulbiCAM3H
Reference: 001
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:17

Manufacturer products View details

06977873520000

FSL-3 FSL-5 FSL-5C FSL-5D

Class IMDR 2017/745On the marketActive device

Manufacturer: Chongqing Fanji Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000046437
UDI-DI: 06977873520000
Basic UDI-DI: 697787352OSLM014E
Reference: FSL-3
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Eye Imaging Camera

VEC-100, VEC-200, VEC-300, VEC-500, VEC-600

Class IMDR 2017/745On the marketActive device

Manufacturer: VISUSCIENCE MEDITECH CO., LTD.
Manufacturer SRN: CN-MF-000032898
UDI-DI: 06976015150303
Basic UDI-DI: 697601515VECRF
Reference: VEC-100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Headlight Loupes

VHL-100, VHL-200, VHL-300, VHL-100D

Class IMDR 2017/745On the marketActive device

Manufacturer: VISUSCIENCE MEDITECH CO., LTD.
Manufacturer SRN: CN-MF-000032898
UDI-DI: 06976015150259
Basic UDI-DI: 697601515VHLSA
Reference: VHL-100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Meibomian Gland Imaging Camera

VMC-100,VMC-200,VMC-300,VMC-500

Class IMDR 2017/745On the marketActive device

Manufacturer: VISUSCIENCE MEDITECH CO., LTD.
Manufacturer SRN: CN-MF-000032898
UDI-DI: 06976015150020
Basic UDI-DI: 697601515VMCS7
Reference: VMC-100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Smartphone Eye Imaging Adaptor

VPA-200,VPA-300

Class IMDR 2017/745On the marketActive device

Manufacturer: VISUSCIENCE MEDITECH CO., LTD.
Manufacturer SRN: CN-MF-000032898
UDI-DI: 06976015150006
Basic UDI-DI: 697601515VPASC
Reference: VPA-200
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

06973047190062

D600

Class IIaMDR 2017/745No longer on the marketActive deviceDirect markingSingle use

Manufacturer: ZD Medical Inc.
Manufacturer SRN: CN-MF-000033176
UDI-DI: 06973047190062
Basic UDI-DI: 697304719006J6
Reference: D600
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Prolinx GmbH
Last updated: 02.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

Multispectral Ocular Examination System

MSI C2010PA

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Thondar Technology Co., Ltd
Manufacturer SRN: CN-MF-000035641
UDI-DI: 06972540430071
Basic UDI-DI: 697254043007HC
Reference: /
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Norway
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

06972413910013

SW-7000

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable

Manufacturer: Tianjin Suowei Electronic Technology Co., Ltd
Manufacturer SRN: CN-MF-000030245
UDI-DI: 06972413910013
Basic UDI-DI: 697241391SW-7000HY
Reference: SW-7000
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Greece
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

06972039970064

OPM500/OPM500C/OPM500D

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen CERTAINN Technology Co., Ltd.
Manufacturer SRN: CN-MF-000016915
UDI-DI: 06972039970064
Basic UDI-DI: 697203997YKAERY
Reference: 535CP3001
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Optomed Lumo Camera

Optomed Lumo

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Optomed Oyj
Manufacturer SRN: FI-MF-000009407
UDI-DI: 06430046260962
Basic UDI-DI: 643004626camera208G
Reference: 41002003
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:54

Manufacturer products View details

Maddox Wing Test

Ophthalmic Binocular Gauge

Class IMDR 2017/745On the market

Manufacturer: Evans (Instruments) Ltd
Manufacturer SRN: GB-MF-000007806
UDI-DI: 05060660330270
Basic UDI-DI: 506066033OBG635873J
Reference: MWT
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
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

Acrylic Test Type, 6m

Vision Testing/Training Chart

Class IMDR 2017/745On the market

Manufacturer: Evans (Instruments) Ltd
Manufacturer SRN: GB-MF-000007806
UDI-DI: 05060660330140
Basic UDI-DI: 506066033VAC168003R
Reference: 908
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
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

Single Panel Test Type

Visual Acuity Light Box

Class IMDR 2017/745On the market

Manufacturer: Evans (Instruments) Ltd
Manufacturer SRN: GB-MF-000007806
UDI-DI: 05060660330102
Basic UDI-DI: 506066033VALB36380L6
Reference: 900(6-L)
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
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

Sting-Ray Table Base

Ophthalmic Instrument Table - line powered

Class IMDR 2017/745On the market

Manufacturer: Evans (Instruments) Ltd
Manufacturer SRN: GB-MF-000007806
UDI-DI: 05060660330027
Basic UDI-DI: 506066033OIT36400AT
Reference: SRT
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
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

UV Inspection Lamp l.e.d.

Woods Lamp

Class IMDR 2017/745On the market

Manufacturer: Evans (Instruments) Ltd
Manufacturer SRN: GB-MF-000007806
UDI-DI: 05060660330010
Basic UDI-DI: 506066033WL36941ZR
Reference: 100
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
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