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06972039970026

Mocean 3000Plus

Class IIaMDDOn the marketMeasuring function

Manufacturer: Shenzhen CERTAINN Technology Co., Ltd.
Manufacturer SRN: CN-MF-000016915
UDI-DI: 06972039970026
Basic UDI-DI: B-06972039970026
Reference: 507CP1001C8
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 14:33

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06972039970019

Mocean 4000

Class IIaMDDOn the marketMeasuring function

Manufacturer: Shenzhen CERTAINN Technology Co., Ltd.
Manufacturer SRN: CN-MF-000016915
UDI-DI: 06972039970019
Basic UDI-DI: B-06972039970019
Reference: 508CP0003
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 14:33

Manufacturer products Authorised representative products Authorised representative actors View details

UNITY® DX

HP-OCT

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Cylite Pty Ltd
Manufacturer SRN: AU-MF-000008611
UDI-DI: 09358863000004
Basic UDI-DI: 93588630HPOCTYC
Reference: UDX
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Finland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

OCTavius

HOCT-1F, HOCT-1

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Huvitz Co., Ltd.
Manufacturer SRN: KR-MF-000015802
UDI-DI: 08800019600473
Basic UDI-DI: 88000196CT001CB
Reference: W2XXCL-21-00008
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:17

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Ophthalmic Optical Coherence Tomography Systems

YG-250K Ultra, YG-250K NF

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TowardPi (Shanghai) Medical Technology Ltd.
Manufacturer SRN: CN-MF-000033952
UDI-DI: 06975994660254
Basic UDI-DI: 697599466YG250KYN
Reference: YG-250K Ultra
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 20:28

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Ophthalmic Optical Coherence Tomography Systems

BM-400K Ultra, BM-400K MAX, BM-400K NF, BM-400K, BM Lite

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TowardPi (Shanghai) Medical Technology Ltd.
Manufacturer SRN: CN-MF-000033952
UDI-DI: 06975994660124
Basic UDI-DI: 697599466BM400KR2
Reference: BM-400K MAX
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 20:28

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Ophthalmic Optical Coherence Tomography Systems

YG-100K Ultra, YG-100K MAX, YG-100K NF, YG-100K PRO, YG Lite

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TowardPi (Shanghai) Medical Technology Ltd.
Manufacturer SRN: CN-MF-000033952
UDI-DI: 06975994660001
Basic UDI-DI: 697599466YG100KXN
Reference: YG-100K MAX
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 20:28

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DREAM OCT

VG100D, VG200D, VG S, VG200C

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Intalight Group Co., Ltd.
Manufacturer SRN: CN-MF-000025982
UDI-DI: 06975480280003
Basic UDI-DI: 697548028VG57
Reference: VG100D
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 19:06

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Ophthalmic Optical Coherence Tomography System

Velite C3000, Velite C3000B, Velite C3000C, Velite C2000, Velite C1000, Velite C800A, Velite C800B

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Guangdong Weiren Meditech Co., Ltd
Manufacturer SRN: CN-MF-000017166
UDI-DI: 06974818590067
Basic UDI-DI: 697481859WR0001TC
Reference: Velite C3000
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:34

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Automated Optical Coherence Tomography and Camera

Vision-700

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Crystalvue Medical Corporation
Manufacturer SRN: TW-MF-000018351
UDI-DI: 04719876420459
Basic UDI-DI: 471987642OPHTHALMICOCTBH
Reference: Vision-700
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Spain
Authorised representative: MDSS GmbH
Last updated: 02.07.2026 00:18

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3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type: Maestro2)

3D Optical Coherence Tomography

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130282766
Basic UDI-DI: 4560126260040U3
Reference: 3D OCT-1(Type: Maestro2)
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 01.07.2026 23:54

Manufacturer products Authorised representative products Authorised representative actors View details

Wide field OCT attachment lens WA-1

Optional Accessories for TOPCON 3D Optical Coherent Tomography

Class IMDR 2017/745On the marketActive device

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04560126268105
Basic UDI-DI: 4560126260041U5
Reference: WA-1
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 01.07.2026 23:49

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SPECTRALIS Platform

SPECTRALIS Platform DMR024

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Heidelberg Engineering GmbH
Manufacturer SRN: DE-MF-000008127
UDI-DI: 04059237001010
Basic UDI-DI: 4059237-SPECTRALIS_HW-GC
Reference: 88033
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:37

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ANTERION

ANTERION DMR007

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Heidelberg Engineering GmbH
Manufacturer SRN: DE-MF-000008127
UDI-DI: 04059237000938
Basic UDI-DI: 4059237ANTERION_HWY7
Reference: 88036
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 20:37

Manufacturer products View details

3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON

Class IIaNot specifiedOn the market

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130283435
Basic UDI-DI: 4560126260040U3
Reference: DRI OCT TRITON
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

DRI OCT Triton (plus)

Class IIaNot specifiedOn the market

Manufacturer: TOPCON CORPORATION
Manufacturer SRN: JP-MF-000003928
UDI-DI: 04571130283442
Basic UDI-DI: 4560126260040U3
Reference: 3D OPTICAL COHERENCE TOMOGRAPHY
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: Netherlands
Authorised representative: Topcon Europe Medical BV
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

OCTavius

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Huvitz Co., Ltd.
Manufacturer SRN: KR-MF-000015802
UDI-DI: 08800019600497
Basic UDI-DI: 88000196CT001CB
Reference: W2XXCL-21-00008
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 25.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Solix

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Optovue, Inc.
Manufacturer SRN: US-MF-000018369
UDI-DI: 00858848006803
Basic UDI-DI: 08588480068037K
Reference: Solix
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

09358863000011

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect markingMeasuring function

Manufacturer: Cylite Pty Ltd
Manufacturer SRN: AU-MF-000008611
UDI-DI: 09358863000011
Basic UDI-DI: 93588630HPOCTYC
Reference: HP-OCT
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.06.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

09369998066353

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect markingMeasuring function

Manufacturer: Cylite Pty Ltd
Manufacturer SRN: AU-MF-000008611
UDI-DI: 09369998066353
Basic UDI-DI: 93588630HPOCTYC
Reference: HP-OCT
EMDN: Z12120121
EMDN description: OPTICAL CONSISTENCY TOMOGRAPHS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.06.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details