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iCare EXPORT

TS03

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850978
Basic UDI-DI: 643003385TS037T
Reference: TS03
EMDN: Z12120182
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

iCare CLINIC

TS02

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850961
Basic UDI-DI: 643003385TS027R
Reference: TS02
EMDN: Z12120182
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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iCare TP022 Probes

TP022

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850947
Basic UDI-DI: 643003385TP0222N
Reference: 114
EMDN: Z12120185
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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iCare IC200

TA031

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

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850909
Basic UDI-DI: 643003385TA031XB
Reference: TA031
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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iCare IC100

TA011

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

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850466
Basic UDI-DI: 643003385TA011X5
Reference: Standard A
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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Sibbo Cyclops

Videonystagmograph

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Sibbo Medical Devices Oy
Manufacturer SRN: FI-MF-000035896
UDI-DI: 06429811118065
Basic UDI-DI: 6429811118CyclopsTB
Reference: SC-001-H
EMDN: Z12120124
EMDN description: VIDEO/ELECTRONYSTAGMOGRAPHS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:46

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Stolik Okulistyczny SE1

Ophthalmic Table SE1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000037042
UDI-DI: 05905913529103
Basic UDI-DI: 5905913529OPTTABLELE
Reference: SE1
EMDN: Z12129001
EMDN description: OPHTHALMOLOGICAL INSTRUMENT STANDS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:10

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Unit Okulistyczny Mini R

Ophthalmic Unit Comfort Maxi R

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000037042
UDI-DI: 05905913529004
Basic UDI-DI: 5905913529OPTUNIT8S
Reference: UN2C
EMDN: Z12129001
EMDN description: OPHTHALMOLOGICAL INSTRUMENT STANDS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:10

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Ophthalmoscope

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: AUG MEDICAL Spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-MF-000019086
UDI-DI: 05904507276454
Basic UDI-DI: 590450727OP27E4
Reference: 20.000.060
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:43

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OKO

Class IMDR 2017/745On the marketActive device

Manufacturer: MEDEN-INMED SP. Z O.O.
Manufacturer SRN: PL-MF-000001670
UDI-DI: 05903684803484
Basic UDI-DI: 590368480M007BM
Reference: -
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:07

Manufacturer products View details

UWF Adapter

Class IMDR 2017/745On the marketActive device

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141403
Basic UDI-DI: 5903293141197000D5
Reference: 197-001
EMDN: Z12120180
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:05

Manufacturer products View details

uSee

uSee Universal System for Eyesight Examination

Class IMDR 2017/745On the marketActive device

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141366
Basic UDI-DI: 590329314100USEEQE
Reference: version 4.0
EMDN: Z1212012082
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - SOFTWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:04

Manufacturer products View details

Spectral Optical Coherence Tomographer REVO nx

REVO 60, REVO 80, REVO nx, REVO nx 130

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141250
Basic UDI-DI: 590329314119REVOTA
Reference: REF 192-110
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:04

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PTS 925 W

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141151
Basic UDI-DI: 5903293141765000E4
Reference: REF 765-001
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 13:04

Manufacturer products View details

PTS 920

Automated Perimeter

Class IMDR 2017/745On the marketActive device

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141120
Basic UDI-DI: 5903293141760000CZ
Reference: REF 760-001
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:04

Manufacturer products View details

PTS 2000

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141113
Basic UDI-DI: 5903293141770000DC
Reference: REF 770-001
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:04

Manufacturer products View details

SOCT

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: OPTOPOL Technology Sp. z o.o.
Manufacturer SRN: PL-MF-000004770
UDI-DI: 05903293141014
Basic UDI-DI: 590329314100SOCTQ4
Reference: 21.5.0
EMDN: Z12120182
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:04

Manufacturer products View details

05713315011597

RetCam Envision

Class IMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315011597
Basic UDI-DI: 5713315NA0001453
Reference: 61-000300
EMDN: Z12120105
EMDN description: FLUOROANGIOGRAPHS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details

1091 ICS Dizcovery

1091 ICS Dizcovery System

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315010736
Basic UDI-DI: 5713315NA001675V
Reference: 8-04-16400
EMDN: Z12120124
EMDN description: VIDEO/ELECTRONYSTAGMOGRAPHS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details

1085, ICS Impulse Vision Denied Solution 2 Kit (50 pcs)

041481

Class IMDR 2017/745On the marketSingle use

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315009983
Basic UDI-DI: 5713315NA001505C
Reference: 041481
EMDN: Z12120124
EMDN description: VIDEO/ELECTRONYSTAGMOGRAPHS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details