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04260539180970

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis (Germany) GmbH
Manufacturer SRN: DE-MF-000007655
UDI-DI: 04260539180970
Basic UDI-DI: 426053918QSWHPFT
Reference: AC-1020221BeGR , SA-1020221BeGR
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

04260539180802

Class IIaMDR 2017/745On the market

Manufacturer: Lumenis (Germany) GmbH
Manufacturer SRN: DE-MF-000007655
UDI-DI: 04260539180802
Basic UDI-DI: 426053918FMTPSB7
Reference: AC-2009596GR
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

04260539180796

Class IMDR 2017/745On the market

Manufacturer: Lumenis (Germany) GmbH
Manufacturer SRN: DE-MF-000007655
UDI-DI: 04260539180796
Basic UDI-DI: 426053918FMADPT8P
Reference: AC-2009595GR
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

04260539180703

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Lumenis (Germany) GmbH
Manufacturer SRN: DE-MF-000007655
UDI-DI: 04260539180703
Basic UDI-DI: 426053918STRKB
Reference: AC-2005210BeGR
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:09

Manufacturer products View details

SCHWIND ATOS

Class IIbMDR 2017/745On the market

Manufacturer: SCHWIND eye-tech-solutions GmbH
Manufacturer SRN: DE-MF-000019049
UDI-DI: 04260157142343
Basic UDI-DI: 426015714E090-FEMTO2J
Reference: 25000
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

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Patient Interface for SCHWIND ATOS

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: SCHWIND eye-tech-solutions GmbH
Manufacturer SRN: DE-MF-000019049
UDI-DI: 04260157142336
Basic UDI-DI: 426015714E090-FEMTOPI4N
Reference: 25132
EMDN: Z12011085
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

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SCHWIND Custom Ablation Manager (CAM)

Class IIbMDR 2017/745On the marketActive device

Manufacturer: SCHWIND eye-tech-solutions GmbH
Manufacturer SRN: DE-MF-000019049
UDI-DI: 04260157140318
Basic UDI-DI: 426015714E071-CAM-SW6W
Reference: 1558510
EMDN: Z12011092
EMDN description: LASER SURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

SCHWIND AMARIS 500E

SCHWIND AMARIS

Class IIbMDR 2017/745On the marketActive device

Manufacturer: SCHWIND eye-tech-solutions GmbH
Manufacturer SRN: DE-MF-000019049
UDI-DI: 04260157140219
Basic UDI-DI: 426015714E057-EXCIMER6M
Reference: 16800
EMDN: Z12011001
EMDN description: EXCIMER SURGICAL LASER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

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FOX IV

LS03500

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.R.C. Laser GmbH
Manufacturer SRN: DE-MF-000009383
UDI-DI: 04260155593185
Basic UDI-DI: 426015559FOXIV9R
Reference: LS03500-GWAB
EMDN: Z12011016
EMDN description: DIODE SURGICAL LASER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

CITO 532

LS09010

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.R.C. Laser GmbH
Manufacturer SRN: DE-MF-000009383
UDI-DI: 04260155590269
Basic UDI-DI: 426015559CITO5329N
Reference: LS09010-S
EMDN: Z12011017
EMDN description: NEODYMIUM SURGICAL LASER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

Q-Las

LS09002

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.R.C. Laser GmbH
Manufacturer SRN: DE-MF-000009383
UDI-DI: 04260155590184
Basic UDI-DI: 426015559Q-LAS3H
Reference: LS09002-LHZO
EMDN: Z12011017
EMDN description: NEODYMIUM SURGICAL LASER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

COBRA

LS09011

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.R.C. Laser GmbH
Manufacturer SRN: DE-MF-000009383
UDI-DI: 04260155590009
Basic UDI-DI: 426015559COBRA4T
Reference: LS09011-LS
EMDN: Z12011017
EMDN description: NEODYMIUM SURGICAL LASER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

04251804500135

Diffusor Laser Probe

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: LifePhotonic GmbH
Manufacturer SRN: DE-MF-000005755
UDI-DI: 04251804500135
Basic UDI-DI: 42518045Fiber1YC
Reference: CD-4L3-30-MX
EMDN: Z12011085
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:07

Manufacturer products View details

04049059511477

Bare Fiber, reusable, sterile

Class IIaMDR 2017/745On the marketSterile

Manufacturer: CeramOptec GmbH
Manufacturer SRN: DE-MF-000005607
UDI-DI: 04049059511477
Basic UDI-DI: 404905922N8
Reference: 500200789
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 30.07.2026 22:54

Manufacturer products View details

LightWalker ST-E ADVANCED

LightWalker/TimeWalker

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: FOTONA, proizvodnja optoelektronskih naprav d.o.o.
Manufacturer SRN: SI-MF-000000126
UDI-DI: 03830054230347
Basic UDI-DI: 3830054230004S7
Reference: M002-6A/2 ADVANCED
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:58

Manufacturer products View details

SP Dynamis

Dynamis/Spectro

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: FOTONA, proizvodnja optoelektronskih naprav d.o.o.
Manufacturer SRN: SI-MF-000000126
UDI-DI: 03830054230101
Basic UDI-DI: 3830054230005S9
Reference: M021-4AF/3
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 21:58

Manufacturer products View details

MoXy™

GreenLight MoXy™ Laser Fibers

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00878953005515
Basic UDI-DI: 01915060000000000000302MK
Reference: 0010-2400
EMDN: Z12011006
EMDN description: DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 30.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

GreenLight HPS™

GreenLight™ HPS Laser Fibers

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00878953004709
Basic UDI-DI: 01915060000000000000303MM
Reference: 0010-2090
EMDN: Z12011006
EMDN description: DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 30.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Laser Surgery Fiber - Dental Surgery Fiber 320µm

Disposable Laser Surgery Fibers, non-sterile

Class IIaMDR 2017/745No longer on the marketDirect markingSingle use

Manufacturer: OBERON GmbH Fiber Technologies
Manufacturer SRN: DE-MF-000008899
UDI-DI: 04260648110295
Basic UDI-DI: ++EOBNLSFdispNNM
Reference: 230027N
EMDN: Z12011085
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:17

Manufacturer products View details

CAPSULO

Fixed-Height Tower

Class IIbMDDOn the marketActive device

Manufacturer: QUANTEL MEDICAL
Manufacturer SRN: FR-MF-000009724
UDI-DI: 03700542626375
Basic UDI-DI: B-03700542626375
Reference: PABX0053C
EMDN: Z12011017
EMDN description: NEODYMIUM SURGICAL LASER
First on market country: Italy
Authorised representative: -
Last updated: 29.07.2026 23:21

Manufacturer products View details