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BRAUN Intense Pulsed Light (IPL)

Intense pulsed light equipment for hair removal, Annex XVI

Class IIaMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Cyden Limited
Manufacturer SRN: UK-MF-000039581
UDI-DI: 08006530438957
Basic UDI-DI: 506035278IPL0144
Reference: A9422
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 22.09.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

BRAUN Intense Pulsed Light (IPL)

Class IIaNot specifiedOn the marketAnnex XVI applicableEMR

Manufacturer: Cyden Limited
Manufacturer SRN: UK-MF-000039581
UDI-DI: 08006530438889
Basic UDI-DI: 506035278IPL0144
Reference: A7342
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 22.09.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

SmoothSkin Pure Mini Lite

Intense pulsed light equipment for hair removal, Annex XVI

Class IIaMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Cyden Limited
Manufacturer SRN: UK-MF-000039581
UDI-DI: 06976933651517
Basic UDI-DI: 506035278IPL0144
Reference: SSB2
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 22.09.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

MAG 206 Professional vers. M3D

MAG 206 Professional

Class IIaMDR 2017/745On the marketActive deviceAnnex XVI applicableDirect markingEMR

Manufacturer: PLATIUMED SRL
Manufacturer SRN: IT-MF-000030734
UDI-DI: 08033055770064
Basic UDI-DI: 803305577PLT11_0GX
Reference: M206P
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 22:14

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U Tip electrode

RADIOSURGICAL UNITS

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016906370
Basic UDI-DI: 8800016902693YC
Reference: PESD11-Ti0003
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

05070004609122

S2 Pigment Removal System

Class IIbMDDNo longer on the marketActive device

Manufacturer: Lightsense Medical Ltd
Manufacturer SRN: UK-MF-000050188
UDI-DI: 05070004609122
Basic UDI-DI: B-05070004609122
Reference: LSA-SYS-S2-MDD-003
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 02.08.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

EMTONE

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableDirect markingEMR

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108784POEMTMEU00
Basic UDI-DI: ++B108084POEUZ6
Reference: A784.201
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Northern Ireland
Authorised representative: BTL ITALIA S.r.l.
Last updated: 15.07.2026 14:51

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EMTONE Applicator BTL-284-01

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableDirect markingEMR

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108284AP01EMTMEU00
Basic UDI-DI: ++B108284AP01EUMM
Reference: A784.210
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Northern Ireland
Authorised representative: BTL ITALIA S.r.l.
Last updated: 15.07.2026 14:50

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E-One Clinic RC

Class IIaMDDOn the marketActive device

Manufacturer: E-SWIN SAS
Manufacturer SRN: FR-MF-000011807
UDI-DI: D-3662824ZT
Basic UDI-DI: B-3662824ZT
Reference: D002AF004Bxxx
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:38

Manufacturer products View details

RENUVA

WFA-01

Class IIbMDDOn the marketActive device

Manufacturer: Wingderm Electro-Optics Ltd.
Manufacturer SRN: CN-MF-000007136
UDI-DI: 06972978060109
Basic UDI-DI: B-06972978060109
Reference: WFA-01
EMDN: X0501
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – LASER
First on market country: Germany
Authorised representative: Prolinx GmbH
Last updated: 06.07.2026 16:18

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DPL

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Australian Aesthetic Devices
Manufacturer SRN: AU-MF-000041530
UDI-DI: 09362129000011
Basic UDI-DI: 93621290DPLIPLMS
Reference: DPL
EMDN: X0502
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 04.07.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

XEN

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Australian Aesthetic Devices
Manufacturer SRN: AU-MF-000041530
UDI-DI: 09362129000004
Basic UDI-DI: 93621290XENLEDRH
Reference: XEN
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 04.07.2026 00:08

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XERF EFFECTOR 60(600)

XERF EFFECTOR 40(300), XERF EFFECTOR 40(600), XERF EFFECTOR 40(900), XERF EFFECTOR 60(600), XERF EFFECTOR 60(900), XERF EFFECTOR 60(1200)

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMRSingle use

Manufacturer: Cynosure Lutronic Technology Corporation
Manufacturer SRN: KR-MF-000047499
UDI-DI: 08800291821399
Basic UDI-DI: 88002918211011BGX
Reference: XERF EFFECTOR 60(600)
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
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

XERF

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Cynosure Lutronic Technology Corporation
Manufacturer SRN: KR-MF-000047499
UDI-DI: 08800291821382
Basic UDI-DI: 88002918211011AGV
Reference: XERF
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
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

S Tip electrode

RADIOSURGICAL UNITS

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016902709
Basic UDI-DI: 8800016902693YC
Reference: VLMC16001
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:16

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CAPACITIVE SMART ELECTRODE Ø19 mm

SMART ELECTRODES

Class IMDR 2017/745On the marketAnnex XVI applicableEMR

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251004388
Basic UDI-DI: 8434251A14D8D9Z000GQ
Reference: ELE0220MED/ELE0220
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

Smart Handle

SMART HANDLES

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251004319
Basic UDI-DI: 8434251A13D8D9Z000FZ
Reference: ACC1099MED/ACC1099
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

SMART RETURN PLATE

SMART RETURN PLATES

Class IMDR 2017/745On the marketAnnex XVI applicableEMR

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251004296
Basic UDI-DI: 8434251A15D8D9Z000HF
Reference: ACC1060MED/ACC1060
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

COMPACT LITE

RADIOFREQUENCY DEVICES COMPACT

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251002612
Basic UDI-DI: 8434251D8Z00000000H9
Reference: ACT0507
EMDN: X0599
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

MTONE EVO-E

Class IIaMDR 2017/745On the marketActive deviceAnnex XVI applicableDirect markingEMR

Manufacturer: M & T S.r.l.
Manufacturer SRN: IT-MF-000043851
UDI-DI: 08057622080080
Basic UDI-DI: 805762208EVOESTKB
Reference: MTONE EVO-E
EMDN: X0501
EMDN description: HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – LASER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:45

Manufacturer products View details