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OptiLight IPL Module Kit

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771808
Basic UDI-DI: 729011777OPTKTJK
Reference: KT-2011950Be
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Bulgaria
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:01

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OPT Handpiece

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771761
Basic UDI-DI: 729011777OPTHPJ2
Reference: SA-20121450Be
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Bulgaria
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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Opti-Tip™

Class IIbMDR 2017/745On the marketActive deviceSingle use

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771747
Basic UDI-DI: 729011777OPTTPK6
Reference: KT-00022901Be
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Bulgaria
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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Digital OptiLight System

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771723
Basic UDI-DI: 729011777OPTN8
Reference: GA-0005500DIG
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Bulgaria
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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DeepFX Microscanner

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771662
Basic UDI-DI: 729011777UPASCNLQ
Reference: AC-00013550Be
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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UltraPulse Focused Incisional 0.2mm & 1.0mm Handpiece Set

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771709
Basic UDI-DI: 729011777UPAHPH5
Reference: AC-00013080Be
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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SurgiTouch™ Scanner

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771471
Basic UDI-DI: 729011777APSCNCG
Reference: SA-1023230Be , SPN-1028780Be
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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AcuPulse™ Upgrade Kit 40 to 40AES-R

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117771532
Basic UDI-DI: 729011777APUGEG
Reference: UG-0000370Be
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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FemTouch™ Standard Panoramic Disposable Tip

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117770795
Basic UDI-DI: 729011777STRP4
Reference: AC-2005209Be
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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FemTouch™ Adaptor Kit

Class IMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117770740
Basic UDI-DI: 729011777FMADPTCU
Reference: AC-2009595Be
EMDN: Z12011080
EMDN description: LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Cyprus
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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ResurFXTM Head

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117770207
Basic UDI-DI: 729011777RFXHPHH
Reference: SA-1146410Be , SPSA-1146410Be , RSP-1146410Be , SA-1146415 , SPSA-1146415
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Netherlands
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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Stellar M22™ ResurFX™ Module Upgrade Kit

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117770191
Basic UDI-DI: 729011777UPKTJQ
Reference: UG-2010701Be , UG-2010702
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Netherlands
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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Multi-SpotTM Nd:YAG Head

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117770160
Basic UDI-DI: 729011777YAGHPG6
Reference: SA-1020220Be , AC-1020220Be , RSA-1020220Be , RAC-1020220Be
EMDN: Z12011019
EMDN description: MULTI–PLATFORM LASER
First on market country: Netherlands
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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UltraPulse® α

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Lumenis Be LTD
Manufacturer SRN: IL-MF-000022063
UDI-DI: 07290117770047
Basic UDI-DI: 729011777UPAMY
Reference: GA-2000011 , GA-2000021
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Germany
Authorised representative: Lumenis (Germany) GmbH
Last updated: 31.07.2026 22:00

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06980294872078

DST-1A,DST-1B,DST-1C,DST-1,DST-500,DST-500A,DST-500B,DST-500C,DST-500D,DST-700,DST-700A,DST-700B,DST-700G,DST-700I,DST-700Q, etc

Class IMDR 2017/745On the market

Manufacturer: HEFEI MT MEDICAL CO.,LTD.
Manufacturer SRN: CN-MF-000008983
UDI-DI: 06980294872078
Basic UDI-DI: 697885897ot001GM
Reference: 06980294872078
EMDN: Z12011202
EMDN description: OPERATING TABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 22:00

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Jetox HDC

JetOx Family

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: TavTech Ltd.
Manufacturer SRN: IL-MF-000039272
UDI-DI: 07290014242616
Basic UDI-DI: 7290014242JetoxEA
Reference: JHDC301
EMDN: Z12019003
EMDN description: WOUND TREATMENT EQUIPMENT
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 21:55

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06980294872061

DST-1A,DST-1B,DST-1C,DST-1,DST-500,DST-500A,DST-500B,DST-500C,DST-500D,DST-700,DST-700A,DST-700B,DST-700G,DST-700I,DST-700Q, etc

Class IMDR 2017/745On the market

Manufacturer: HEFEI MT MEDICAL CO.,LTD.
Manufacturer SRN: CN-MF-000008983
UDI-DI: 06980294872061
Basic UDI-DI: 697885897ot001GM
Reference: MT-EOT01
EMDN: Z12011202
EMDN description: OPERATING TABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:54

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Safe Care Med

STERILE SURGICAL SCISSORS

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Anhui Medfaith Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000030042
UDI-DI: 06977822270017
Basic UDI-DI: 697782227MFXSUQ
Reference: S/MFXS119SB2-SCM
EMDN: Z12019085
EMDN description: VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - CONSUMABLES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:52

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Operation Lamp

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Triup International Corp.
Manufacturer SRN: CN-MF-000048540
UDI-DI: 06976118070652
Basic UDI-DI: 697611807TR700SCRY
Reference: TR2013-620
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 21:50

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Operation Lamp

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Triup International Corp.
Manufacturer SRN: CN-MF-000048540
UDI-DI: 06976118070140
Basic UDI-DI: 697611807TR700DCQK
Reference: TR2013-620/620
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 21:50

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