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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 09:11

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Active filter:EMDN:Z12011005

64 device results listed.

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REX-CO

Class IIbMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100254
Basic UDI-DI: B-08800042100254
Reference: AMI-CL-0421
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:26

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DX300

Class IIbMDDOn the market

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100230
Basic UDI-DI: B-08800042100230
Reference: AMI-CL-0541
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:26

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DI-REX

Class IIbMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100162
Basic UDI-DI: B-08800042100162
Reference: AMI-CL-0221
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:26

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BX300

Class IIbMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100155
Basic UDI-DI: B-08800042100155
Reference: AMI-CL-0531
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:26

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NEOXEL

Class IIbMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100100
Basic UDI-DI: B-08800042100100
Reference: AMI-CL-0511
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:25

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DERMAXEL

Class IIbMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100063
Basic UDI-DI: B-08800042100063
Reference: AMI-CL-0411
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:25

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BIOXEL

Class IIbMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100018
Basic UDI-DI: B-08800042100018
Reference: BIOXEL
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:25

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Ultra pulse CO2 fractional laser

PENTAGON GRAND

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: DAEJU MEDITECH ENGINEERING CO., LTD
Manufacturer SRN: KR-MF-000020683
UDI-DI: 08800017500140
Basic UDI-DI: B-08800017500140
Reference: DJMD0003
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Javitech Consulting GmbH
Last updated: 09.07.2026 19:59

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FRAXIS

CO2 laser system

Class IIbMDDOn the marketActive device

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016903959
Basic UDI-DI: B-08800016903959
Reference: FRAXIS
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 09.07.2026 19:57

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FRAXIS DUO

CO2 laser system and High Frequency Surgical System with sterile micro needle electrodes

Class IIbMDDOn the marketActive device

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016903621
Basic UDI-DI: B-08800016903621
Reference: FRAXIS DUO
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 09.07.2026 19:57

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GLOBALIPL

US800

Class IIbMDDOn the marketActive deviceReusableSingle use

Manufacturer: Beijing Globalipl Development Co., Ltd
Manufacturer SRN: CN-MF-000010924
UDI-DI: 06973494938026
Basic UDI-DI: B-06973494938026
Reference: US800
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 17:19

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MED-870+

Class IIbMDDOn the marketActive device

Manufacturer: Beijing KES Biology Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000002099
UDI-DI: 06971513122159
Basic UDI-DI: B-06971513122159
Reference: CO2 MED-870+
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

Affirm 14mm Tip

100-7004-814

Class IIbMDDOn the market

Manufacturer: Cynosure LLC
Manufacturer SRN: US-MF-000010200
UDI-DI: 00841494100513
Basic UDI-DI: B-00841494100513
Reference: 100-7004-814
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Netherlands
Authorised representative: Cynosure B.V.
Last updated: 05.07.2026 07:11

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Affirm 10mm Tip

100-7004-910

Class IIbMDDOn the market

Manufacturer: Cynosure LLC
Manufacturer SRN: US-MF-000010200
UDI-DI: 00841494100506
Basic UDI-DI: B-00841494100506
Reference: 100-7004-910
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Netherlands
Authorised representative: Cynosure B.V.
Last updated: 05.07.2026 07:11

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Laser System main body (Including Handpiece)

eCO2 DENTA

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Cynosure Lutronic Technology Corporation
Manufacturer SRN: KR-MF-000047499
UDI-DI: 08809447657363
Basic UDI-DI: 88002918210409BJ3
Reference: eCO2 DENTA
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Laser System main body (Including Handpiece)

eCO2 3D

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Cynosure Lutronic Technology Corporation
Manufacturer SRN: KR-MF-000047499
UDI-DI: 08800291821153
Basic UDI-DI: 88002918210409AHZ
Reference: eCO2 3D
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Silklase

CDL

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMRReusable

Manufacturer: INTERmedic Arfran s.a.
Manufacturer SRN: ES-MF-000038662
UDI-DI: 08435259608226
Basic UDI-DI: 84352596CDLZH
Reference: 31063
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

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SLIM EVOLUTION

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Lasering s.r.l.
Manufacturer SRN: IT-MF-000020505
UDI-DI: 08056477090008
Basic UDI-DI: 805647709SLIMEVO47
Reference: AT0231
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:16

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HEMERA

HEMERA/HELIX

Class IIbMDR 2017/745On the marketActive device

Manufacturer: DEKA M.E.L.A. SRL
Manufacturer SRN: IT-MF-000007389
UDI-DI: 08034108513089
Basic UDI-DI: 803410851M133XXR5
Reference: M133B1
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:26

Manufacturer products View details

SmartXide PRO

SMARTXIDE family

Class IIbMDR 2017/745On the marketActive device

Manufacturer: DEKA M.E.L.A. SRL
Manufacturer SRN: IT-MF-000007389
UDI-DI: 08034108512693
Basic UDI-DI: 803410851M079XXSL
Reference: M079BH1
EMDN: Z12011005
EMDN description: CARBON DIOXIDE SURGICAL LASER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:26

Manufacturer products View details