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PurePoint

PurePoint Laser System

Class IIbMDR 2017/745On the marketActive deviceReusable

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380657505975
Basic UDI-DI: 038065GMN000074H8
Reference: 8065750597
EMDN: Z12120202
EMDN description: LASER PHOTOCOAGULATORS
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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Intrepid

Intrepid I/A Tips

Class IIaMDR 2017/745On the marketCMR substanceReusable

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380657510122
Basic UDI-DI: 038065GMN000080H3
Reference: 8065751012
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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00380657503537

Small Parts Kit (Bulk Non-Sterile)

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380657503537
Basic UDI-DI: 038065GMN000300GS
Reference: 8065750353
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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TurboSonics, MicroTip

TurboSonics U/S Tips

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380657403028
Basic UDI-DI: 038065GMN000198HT
Reference: 30RTS
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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00380650004703

Small Parts Kit (Sterile)

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650004703
Basic UDI-DI: 038065GMN000197HR
Reference: 8065000470
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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WaveLight

Laser Patient Interface

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650004529
Basic UDI-DI: 038065GMN000169HL
Reference: 1515
EMDN: Z12120285
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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Unity

Viscous Fluid Control (VFC) Pak

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650003935
Basic UDI-DI: 038065GMN000202GR
Reference: 8065000393
EMDN: Z12120285
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

UNITY

Anterior Segment Console

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650002976
Basic UDI-DI: 038065GMN000192HF
Reference: 8065000297
EMDN: Z1212020701
EMDN description: PHACO-EMULSIFIERS
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

UNITY

Combined Anterior & Posterior Segment Console

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650002969
Basic UDI-DI: 038065GMN000067HB
Reference: 8065000296
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

Constellation

Posterior Segment Packs

Class IIbMDR 2017/745Not intended for EU marketActive deviceCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650002587
Basic UDI-DI: 038065GMN000188HQ
Reference: 8065000258
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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00380650002525

Fiber Optic Probes

Class IIaMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650002525
Basic UDI-DI: 038065GMN000205GX
Reference: 8065000252
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

00380650002365

Laser Probes

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650002365
Basic UDI-DI: 038065GMN000178HM
Reference: 8065000236
EMDN: Z12120285
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

Ozil

Phacoemulsification Handpieces

Class IIbMDR 2017/745On the marketActive deviceCMR substanceDirect marking

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650002150
Basic UDI-DI: 038065GMN000068HD
Reference: 8065000215
EMDN: Z1212020780
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

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UNITY

Fragmentation Packs

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650001252
Basic UDI-DI: 038065GMN000072H4
Reference: 8065000125
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

Constellation

Combined Anterior & Posterior Segment Packs

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650000934
Basic UDI-DI: 038065GMN000187HN
Reference: 8065000093
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

UNITY

Vitrectomy Probes

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380650000187
Basic UDI-DI: 038065GMN000073H6
Reference: 8065000018
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

04049368226017

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Geuder AG
Manufacturer SRN: DE-MF-000008044
UDI-DI: 04049368226017
Basic UDI-DI: 4049368200APJ
Reference: G-90002
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:56

Manufacturer products View details

Valeda LumiKey

Class IMDR 2017/745On the market

Manufacturer: LumiThera, Inc.
Manufacturer SRN: US-MF-000029866
UDI-DI: +B749300003030
Basic UDI-DI: ++B749002KJ
Reference: 300003
EMDN: Z12120280
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

Brock String

Cross Eye Convergence Trainer

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151330W
Basic UDI-DI: ++B091BrockStringHD
Reference: 15133
EMDN: Z12120201
EMDN description: CROSS–EYE CONVERGENCE TRAINERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

LB-14 Large Vertical Prism Bar

Prism Bar

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111110O
Basic UDI-DI: ++B091PrismBarsE2
Reference: 11111
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details