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Ultra-widefield Retinal Slit Scanner GAIA

RETINAL CAMERA

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268372
Basic UDI-DI: 4560126260020TV
Reference: 1070437-01
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 16.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Perivist Compact III

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Vistec GmbH
Manufacturer SRN: DE-MF-000006316
UDI-DI: 04260375770175
Basic UDI-DI: 42603757PerivistPX
Reference: 404.01.300
EMDN: Z1212012003
EMDN description: PERIPHERAL VISION ANALYSERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:18

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Anzeigegabel mit Landoltring

Anzeigegabel

Class IMDR 2017/745On the market

Manufacturer: OCULUS Optikgeräte GmbH
Manufacturer SRN: DE-MF-000012227
UDI-DI: 04049584006578
Basic UDI-DI: 40495840058PK
Reference: 46970
EMDN: Z1212012080
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:30

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Universal-Messbrille UB 4

Manuelle Refraktion

Class IMDR 2017/745On the market

Manufacturer: OCULUS Optikgeräte GmbH
Manufacturer SRN: DE-MF-000012227
UDI-DI: 04049584005717
Basic UDI-DI: 404958416PY
Reference: 42500
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:30

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Praxisbrille für Kinder mit fester Nasenauflage

Praxisbrillen

Class IMDR 2017/745On the market

Manufacturer: OCULUS Optikgeräte GmbH
Manufacturer SRN: DE-MF-000012227
UDI-DI: 04049584005656
Basic UDI-DI: 404958427Q5
Reference: 42480
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:29

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Prismengläserkasten S, vergütet

Messgläser

Class IMDR 2017/745On the market

Manufacturer: OCULUS Optikgeräte GmbH
Manufacturer SRN: DE-MF-000012227
UDI-DI: 04049584001153
Basic UDI-DI: 404958429Q9
Reference: 33116
EMDN: Z1212012080
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:29

Manufacturer products View details

04049368226178

Class IIbNot specifiedOn the marketSingle use

Manufacturer: Geuder AG
Manufacturer SRN: DE-MF-000008044
UDI-DI: 04049368226178
Basic UDI-DI: 4049368200BPL
Reference: G-90030
EMDN: Z1212020780
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:29

Manufacturer products View details

04049368226000

VIVOS device system

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Geuder AG
Manufacturer SRN: DE-MF-000008044
UDI-DI: 04049368226000
Basic UDI-DI: 4049368200APJ
Reference: G-90001
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:29

Manufacturer products View details

nun

WFE-02S

Class IMDR 2017/745On the marketActive device

Manufacturer: WikiOptics Inc.
Manufacturer SRN: KR-MF-000026369
UDI-DI: 08800065600007
Basic UDI-DI: 08800065600007H6
Reference: 08800065600007
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Poland
Authorised representative: JaviTech e.K.
Last updated: 16.07.2026 07:05

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Patient Interface Device

70-00050-001

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: LENSAR
Manufacturer SRN: US-MF-000008522
UDI-DI: 00850062486027
Basic UDI-DI: 08677440001ALLYUN
Reference: 70-00036-001
EMDN: Z12120285
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

Macula Explorer

Macula Explorer v1.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Altris Inc.
Manufacturer SRN: US-MF-000043686
UDI-DI: 08600098265101
Basic UDI-DI: 08600098265MacEx5N
Reference: 1
EMDN: Z12120282
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: ALTRIS EUROPE, SOCIEDAD LIMITADA
Last updated: 16.07.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

Assure Plus

Assure Plus 1.0.0

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Eyetelligence Pty Ltd, an Optain Health Company
Manufacturer SRN: AU-MF-000044109
UDI-DI: 00860011973201
Basic UDI-DI: 08600119732APVN
Reference: Assure Plus 1.0.0
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Altris

Altris AI v2.1.1

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Altris Inc.
Manufacturer SRN: US-MF-000043686
UDI-DI: 00860009826502
Basic UDI-DI: 0860009826527W
Reference: 1
EMDN: Z12120182
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: ALTRIS EUROPE, SOCIEDAD LIMITADA
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

iVue 80

iVue

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Optovue, Inc.
Manufacturer SRN: US-MF-000018369
UDI-DI: 00858848006773
Basic UDI-DI: 085884800677383
Reference: iVue 100
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

Solix Essential

Solix

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Optovue, Inc.
Manufacturer SRN: US-MF-000018369
UDI-DI: 00858848006261
Basic UDI-DI: 08588480068037K
Reference: Solix Essential
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

00850088816006

Stereo Test

Class IMDR 2017/745On the market

Manufacturer: Vision Assessment Corporation
Manufacturer SRN: US-MF-000047190
UDI-DI: 00850088816006
Basic UDI-DI: 08600075895VAC26757E
Reference: 1012
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

iVue

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: Optovue, Inc.
Manufacturer SRN: US-MF-000018369
UDI-DI: 00858848006766
Basic UDI-DI: 085884800676686
Reference: iVue 100
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

PASCAL LIO

Laser Indirect Ophthalmoscope (LIO)

Class IMDR 2017/745On the market

Manufacturer: Iridex Corporation
Manufacturer SRN: US-MF-000029814
UDI-DI: 00813125015428
Basic UDI-DI: 081312501LIO9E
Reference: SA-06620
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

OMA (810 nm)

Operating Microscope Adapter (OMA)

Class IMDR 2017/745On the market

Manufacturer: Iridex Corporation
Manufacturer SRN: US-MF-000029814
UDI-DI: 00813125010584
Basic UDI-DI: 081312501OMA9D
Reference: 13411
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

SLA Symphony 3 (532 nm & 810 nm)

Slit Lamp Adapter (SLA)

Class IMDR 2017/745On the market

Manufacturer: Iridex Corporation
Manufacturer SRN: US-MF-000029814
UDI-DI: 00813125010478
Basic UDI-DI: 081312501SLA9W
Reference: 31122-02
EMDN: Z12120108
EMDN description: SLIT LAMPS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details