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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

EVA NEXUS, Phaco vitrectomy NCBF system including laser with SMA connector

EVA NEXUS, Phaco vitrectomy NCBF system including laser with SMA connector

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030265
Basic UDI-DI: B-08717872030265
Reference: 9000.COM06
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco vitrectomy NCBF system including laser with DORC connector

EVA NEXUS, Phaco vitrectomy NCBF system including laser with DORC connector

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030258
Basic UDI-DI: B-08717872030258
Reference: 9000.COM05
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco vitrectomy NCBF system

EVA NEXUS, Phaco vitrectomy NCBF system

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030241
Basic UDI-DI: B-08717872030241
Reference: 9000.COM04
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco vitrectomy system including laser with SMA connector

EVA NEXUS, Phaco vitrectomy system including laser with SMA connector

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030234
Basic UDI-DI: B-08717872030234
Reference: 9000.COM03
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco vitrectomy system including laser with DORC connector

EVA NEXUS, Phaco vitrectomy system including laser with DORC connector

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030227
Basic UDI-DI: B-08717872030227
Reference: 9000.COM02
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco vitrectomy system

EVA NEXUS, Phaco vitrectomy system

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030210
Basic UDI-DI: B-08717872030210
Reference: 9000.COM01
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco emulsification NCBF system

EVA NEXUS, Phaco emulsification NCBF system

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030203
Basic UDI-DI: B-08717872030203
Reference: 9000.ANT02
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

EVA NEXUS, Phaco emulsification system

EVA NEXUS, Phaco emulsification system

Class IIbMDDOn the marketActive device

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Manufacturer SRN: NL-MF-000015696
UDI-DI: 08717872030197
Basic UDI-DI: B-08717872030197
Reference: 9000.ANT01
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 15:05

Manufacturer products View details

TS01

Class IMDDNo longer on the marketActive device

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850534
Basic UDI-DI: B-06430033850534
Reference: TS01
EMDN: Z12120182
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 14:08

Manufacturer products View details

Non-Contact Tonometer NCT-200

NCT-200

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008319989
Basic UDI-DI: B-04540008319989
Reference: NT253
EMDN: Z12120122
EMDN description: TONOMETERS
First on market country: Italy
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

Specular Microscope SPM-700

SPM-700

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008319965
Basic UDI-DI: B-04540008319965
Reference: SP003
EMDN: Z12120110
EMDN description: CORNEAL CONFOCAL MICROSCOPES
First on market country: Belgium
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

REF TOPO RET-700

RET-700

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008310603
Basic UDI-DI: B-04540008310603
Reference: RT003
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Italy
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Refractometer ACCUREF R-800

R-800

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008310443
Basic UDI-DI: B-04540008310443
Reference: RE253
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Germany
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Ref-Keratometer ACCUREF K-900

K-900

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008310436
Basic UDI-DI: B-04540008310436
Reference: RK453
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: France
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

BINOCULAR ACCOMMODATION AUTO REF/KERATOMETER WAM-5500

WAM-5500

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008310320
Basic UDI-DI: B-04540008310320
Reference: RK363
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Czechia
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

NATURAL VISION AUTO REFKERATOMETER NVISION-K5001

NVISION-K5001

Class IMDDOn the marketActive deviceMeasuring function

Manufacturer: Rexxam Co.,Ltd. Kagawa Factory
Manufacturer SRN: JP-MF-000004361
UDI-DI: 04540008310030
Basic UDI-DI: B-04540008310030
Reference: RK353
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Italy
Authorised representative: REXXAM CZECH s.r.o.
Last updated: 05.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

ENG 4000 (Electronystagmograph)

ENG 4000

Class IIaMDDOn the marketActive device

Manufacturer: G. Heinemann Medizintechnik GmbH
Manufacturer SRN: DE-MF-000009705
UDI-DI: 04260548936506
Basic UDI-DI: B-04260548936506
Reference: 80-1100
EMDN: Z12120124
EMDN description: VIDEO/ELECTRONYSTAGMOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:26

Manufacturer products View details

VisuMax

Class IIbMDDOn the market

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471095036
Basic UDI-DI: B-04049471095036
Reference: 1345-518
EMDN: Z1212020501
EMDN description: MICROKERATOME LASERS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 05:23

Manufacturer products View details

Snellen Eye Chart, Red and Green Bar Visual Acuity Test

Vision Testing Chart

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Precision Vision, Inc.
Manufacturer SRN: US-MF-000008456
UDI-DI: 00811286030007
Basic UDI-DI: 081128603PVChartsLF
Reference: 5010
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 05.08.2026 01:08

Manufacturer products Authorised representative products Authorised representative actors View details