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AccuTip Covers, 100/bx, individually wrapped

Class IIaMDDOn the marketContains latexSingle use

Manufacturer: Accutome Inc. DBA Keeler USA
Manufacturer SRN: US-MF-000036181
UDI-DI: 00897826002086
Basic UDI-DI: B-00897826002086
Reference: AX9950
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

AccuPen

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Accutome Inc. DBA Keeler USA
Manufacturer SRN: US-MF-000036181
UDI-DI: 00897826002000
Basic UDI-DI: B-00897826002000
Reference: 24-3000
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

EyeArt

2.1.0

Class IIaMDDOn the marketActive device

Manufacturer: Eyenuk, Inc.
Manufacturer SRN: US-MF-000004180
UDI-DI: 00860000470018
Basic UDI-DI: B-00860000470018
Reference: 2.1.0
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:44

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Pachette 4

DGH 555B

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: DGH Technology, Inc.
Manufacturer SRN: US-MF-000008833
UDI-DI: 00857377006018
Basic UDI-DI: B-00857377006018
Reference: DGH 555B
EMDN: Z12120116
EMDN description: PACHYMETERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:33

Manufacturer products Authorised representative products Authorised representative actors View details

Pachmate 2

DGH 55B

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: DGH Technology, Inc.
Manufacturer SRN: US-MF-000008833
UDI-DI: 00857377006001
Basic UDI-DI: B-00857377006001
Reference: DGH 55B
EMDN: Z12120116
EMDN description: PACHYMETERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:33

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MaculoScope

Class IIaMDDNo longer on the marketActive deviceMeasuring function

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007412
Basic UDI-DI: B-00855730007412
Reference: D130
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

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PSG Pattern Stimulator:

PSG Pattern Stimulator

Class IIaMDDNo longer on the marketActive deviceMeasuring function

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007405
Basic UDI-DI: B-00855730007405
Reference: D217
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

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ColorBurst

Class IIaMDDOn the marketActive device

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007399
Basic UDI-DI: B-00855730007399
Reference: D213
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

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ColorFlash

Class IIaMDDOn the marketActive device

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007375
Basic UDI-DI: B-00855730007375
Reference: D382
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

EER

Class IIaMDDOn the marketActive device

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007368
Basic UDI-DI: B-00855730007368
Reference: D366
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Envoy

Class IIaMDDOn the marketActive device

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007351
Basic UDI-DI: B-00855730007351
Reference: D352
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

ColorDome

Class IIaMDDOn the marketActive device

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007344
Basic UDI-DI: B-00855730007344
Reference: D125
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Attache

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007313
Basic UDI-DI: B-00855730007313
Reference: D341
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007306
Basic UDI-DI: B-00855730007306
Reference: D315
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

Profile

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00855730007290
Basic UDI-DI: B-00855730007290
Reference: D310
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

Standalone

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Diagnosys LLC
Manufacturer SRN: US-MF-000002934
UDI-DI: 00850594007004
Basic UDI-DI: B-00850594007004
Reference: D175
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Ireland
Authorised representative: Diagnosys Vision Limited
Last updated: 05.07.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Vision Testing System

Class IIaMDDOn the marketActive device

Manufacturer: Diopsys, Inc.
Manufacturer SRN: US-MF-000038933
UDI-DI: 00850514007077
Basic UDI-DI: B-00850514007077
Reference: 4028-0005-00
EMDN: Z12120103
EMDN description: ELECTRORETINOGRAPHS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 05.07.2026 11:09

Manufacturer products Authorised representative products Authorised representative actors View details

M&S Technologies Smart System® Virtual Reality Headset System

VR-1002H

Class IMDDOn the marketActive device

Manufacturer: M&S Technologies
Manufacturer SRN: US-MF-000048924
UDI-DI: 00850040295122
Basic UDI-DI: B-00850040295122
Reference: VR-1002H
EMDN: Z12120192
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Certification Company
Last updated: 05.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

NeurOptics

PLR-4000 Pupilometer System

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: NeurOptics, Inc.
Manufacturer SRN: US-MF-000013240
UDI-DI: 00850010118123
Basic UDI-DI: B-00850010118123
Reference: PLR-4000-SYS
EMDN: Z12120125
EMDN description: PUPILLOMETERS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

NeurOptics

VIP-400 Pupillometer System

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: NeurOptics, Inc.
Manufacturer SRN: US-MF-000013240
UDI-DI: 00850010118116
Basic UDI-DI: B-00850010118116
Reference: VIP-400-SYS
EMDN: Z12120125
EMDN description: PUPILLOMETERS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details