Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

01.08.2026 09:11

Sync status

Successful

Device

2989310

Actor

47520

Certificate

3174

Filters

Show filters

Active filter:EMDN:Z12011005

64 device results listed.

Page 2 / 4

CSV XML

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

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