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EVA, anterior machine NCBF

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872029979
Basic UDI-DI: B-08717872029979
Reference: 8000.ANT02
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.08.2026 01:13

Manufacturer products View details

EVA, anterior machine

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872029962
Basic UDI-DI: B-08717872029962
Reference: 8000.ANT01
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.08.2026 01:13

Manufacturer products View details

EVA, combined machine including Laser (SMA connector) with conventional Foot Pedals

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872020419
Basic UDI-DI: B-08717872020419
Reference: 8000.COM08
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.08.2026 01:13

Manufacturer products View details

EVA, combined machine with conventional Foot Pedal

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872020402
Basic UDI-DI: B-08717872020402
Reference: 8000.COM07
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 06.08.2026 01:13

Manufacturer products View details

00811608010014

Binocular Indirect Ophthalmoscope (BIO) Lens

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010014
Basic UDI-DI: 81160801BIOSE
Reference: V15LC
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

ERG-Jet

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Fabrinal SA
Manufacturer SRN: CH-MF-000015863
UDI-DI: +EFABF062
Basic UDI-DI: ++EFABF064B
Reference: F-06
EMDN: Z12120185
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: Veranex Germany GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Tran Goniowash

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Fabrinal SA
Manufacturer SRN: CH-MF-000015863
UDI-DI: +EFABTG012
Basic UDI-DI: ++EFABTG01V2
Reference: TG-01
EMDN: Z12129085
EMDN description: VARIOUS OPHTALMOLOGY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: Veranex Germany GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010021

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010021
Basic UDI-DI: 81160801BIOSE
Reference: V20LC
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010052

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010052
Basic UDI-DI: 81160801BIOSE
Reference: V20LC-BE
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010083

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010083
Basic UDI-DI: 81160801BIOSE
Reference: V20LC-GD
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010076

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010076
Basic UDI-DI: 81160801BIOSE
Reference: V20LC-GN
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010069

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010069
Basic UDI-DI: 81160801BIOSE
Reference: V20LC-PE
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010045

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010045
Basic UDI-DI: 81160801BIOSE
Reference: V20LC-RD
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

00811608010090

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Volk Optical Inc.
Manufacturer SRN: US-MF-000017843
UDI-DI: 00811608010090
Basic UDI-DI: 81160801BIOSE
Reference: V20LC-SR
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: -
Authorised representative: Rudolf Riester GmbH
Last updated: 05.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

RETINAL CAMERA TRC-50DX

RETINAL CAMERA

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130283503
Basic UDI-DI: 4560126260020TV
Reference: TRC-50DX (Type IA)
EMDN: Z12120105
EMDN description: FLUOROANGIOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 05.08.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

05391531761818

FRMX2

Class IMDR 2017/745On the marketActive device

Manufacturer: Scope Ophthalmics Limited
Manufacturer SRN: IE-MF-000037510
UDI-DI: 05391531761818
Basic UDI-DI: 5391531optaseMX201J2
Reference: FRMX2
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 05.08.2026 16:07

Manufacturer products View details

MiiS Horus Scope

DSC series

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872710080
Basic UDI-DI: 47198727100007L
Reference: ULMA Control Unit UR-3
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Denmark
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

RETINAL CAMERA TRC-50DX

RETINAL CAMERA

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130283497
Basic UDI-DI: 4560126260020TV
Reference: TRC-50DX
EMDN: Z12120105
EMDN description: FLUOROANGIOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 05.08.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF0000389680021386L

OPO71

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Johnson & Johnson Surgical Vision, Inc.
Manufacturer SRN: US-MF-000038968
UDI-DI: D-USMF0000389680021386L
Basic UDI-DI: B-USMF0000389680021386L
Reference: OPO71
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 05.08.2026 15:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF0000389680021356E

OPO65

Class IIaMDDOn the marketSterile

Manufacturer: Johnson & Johnson Surgical Vision, Inc.
Manufacturer SRN: US-MF-000038968
UDI-DI: D-USMF0000389680021356E
Basic UDI-DI: B-USMF0000389680021356E
Reference: OPO65
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 05.08.2026 15:35

Manufacturer products Authorised representative products Authorised representative actors View details