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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

Manufacturer products View details

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

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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

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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

FRACTIONAL APPLICATOR BTL-754-4

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108754AP1ZMEU00
Basic UDI-DI: ++B108754APEUYJ
Reference: 754-AP1Z-M
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: -
Authorised representative: BTL ITALIA S.r.l.
Last updated: 30.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors 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

SDL-B

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Beijing Sincoheren Science and Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000023133
UDI-DI: 69704533101215D
Basic UDI-DI: 69704533101215D
Reference: SDL-B
EMDN: Z12011016
EMDN description: DIODE SURGICAL LASER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

04049059511484

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: CeramOptec GmbH
Manufacturer SRN: DE-MF-000005607
UDI-DI: 04049059511484
Basic UDI-DI: 404905922N8
Reference: 500200790
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:51

Manufacturer products View details

04049059511491

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: CeramOptec GmbH
Manufacturer SRN: DE-MF-000005607
UDI-DI: 04049059511491
Basic UDI-DI: 404905922N8
Reference: 500200791
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:51

Manufacturer products View details

04049059511507

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: CeramOptec GmbH
Manufacturer SRN: DE-MF-000005607
UDI-DI: 04049059511507
Basic UDI-DI: 404905922N8
Reference: 500200792
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:51

Manufacturer products View details

04049059514485

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: CeramOptec GmbH
Manufacturer SRN: DE-MF-000005607
UDI-DI: 04049059514485
Basic UDI-DI: 404905922N8
Reference: 501200314
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:51

Manufacturer products View details

04049059514492

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: CeramOptec GmbH
Manufacturer SRN: DE-MF-000005607
UDI-DI: 04049059514492
Basic UDI-DI: 404905922N8
Reference: 501200315
EMDN: Z12011099
EMDN description: LASER SURGERY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 22:51

Manufacturer products View details