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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

Manufacturer products Authorised representative products Authorised representative actors View details

CORE FILL PLUS

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableMedicinal productSingle useSterile

Manufacturer: YURIM MEDICAL Co., Ltd.
Manufacturer SRN: KR-MF-000009011
UDI-DI: 08809684739617
Basic UDI-DI: 880968473961COREFILLBS
Reference: CORE FILL PLUS SUB-Q
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: Italy
Safety summary (SSCP/SSP): YRM- KR-MF-000020813-03 · Rev. 4
Authorised representative: SOAR & PARTNERS Sp. z o.o.
Last updated: 03.07.2026 20:59

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08809448822760

TTP

Class IMDR 2017/745On the market

Manufacturer: JMBIOTECH
Manufacturer SRN: KR-MF-000029867
UDI-DI: 08809448822760
Basic UDI-DI: 88094488TTP_CosmeticGS
Reference: TTP 324(13)-32G
EMDN: X0302
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – NON RESORBABLE
First on market country: Belgium
Authorised representative: AF Pharma Service Europe SL
Last updated: 03.07.2026 20:57

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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

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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

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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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ULTRAFORMER MPT

ULTRASOUND THERAPY EQUIPMENT

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicable

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016902518
Basic UDI-DI: 8800016902518XR
Reference: UF4MPTM02
EMDN: X0402
EMDN description: EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:16

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ADIPOLOGIE

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicable

Manufacturer: Aesthetic Rent S.L.
Manufacturer SRN: ES-MF-000047678
UDI-DI: 08437026917012
Basic UDI-DI: 8437025783AD02ZP
Reference: ADP02
EMDN: X0402
EMDN description: EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:16

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DEEP SLIM REVOLUTION

DEEP

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicable

Manufacturer: Aesthetic Rent S.L.
Manufacturer SRN: ES-MF-000047678
UDI-DI: 08437026917005
Basic UDI-DI: 8437025783DS014Q
Reference: DS01S1
EMDN: X0402
EMDN description: EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:16

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CORE FILL PLUS

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableMedicinal productSingle useSterile

Manufacturer: YURIM MEDICAL Co., Ltd.
Manufacturer SRN: KR-MF-000009011
UDI-DI: 08809684749128
Basic UDI-DI: 880968473961COREFILLBS
Reference: COREFILL PLUS DEEP
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: -
Safety summary (SSCP/SSP): YRM- KR-MF-000020813-03 · Rev. 4
Authorised representative: SOAR & PARTNERS Sp. z o.o.
Last updated: 03.07.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

CORE FILL PLUS

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableMedicinal productSingle useSterile

Manufacturer: YURIM MEDICAL Co., Ltd.
Manufacturer SRN: KR-MF-000009011
UDI-DI: 08809684749135
Basic UDI-DI: 880968473961COREFILLBS
Reference: CORE FILL PLUS FINE
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: -
Safety summary (SSCP/SSP): YRM- KR-MF-000020813-03 · Rev. 4
Authorised representative: SOAR & PARTNERS Sp. z o.o.
Last updated: 03.07.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

CORE FILL PLUS

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableMedicinal productSingle useSterile

Manufacturer: YURIM MEDICAL Co., Ltd.
Manufacturer SRN: KR-MF-000009011
UDI-DI: 08809684749142
Basic UDI-DI: 880968473961COREFILLBS
Reference: COREFILL PLUS AQ
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: -
Safety summary (SSCP/SSP): YRM- KR-MF-000020813-03 · Rev. 4
Authorised representative: SOAR & PARTNERS Sp. z o.o.
Last updated: 03.07.2026 14:44

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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

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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

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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

Delighter Duo 2000

Class IIaMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Panestetic S.R.L.
Manufacturer SRN: IT-MF-000028477
UDI-DI: 08057284401087
Basic UDI-DI: 805728440DELIGHTERDD
Reference: P221/2000/S
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 11:31

Manufacturer products View details

VF LASERS VF6000

VF6000

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

Manufacturer: VF SISTEMI ITALIA S.R.L.
Manufacturer SRN: IT-MF-000054326
UDI-DI: 08056633360006
Basic UDI-DI: 805663336VF600086
Reference: VF6000-3600W-808
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 11:19

Manufacturer products View details

80537820605116

218806SA, 218808SB, 218810SB, 218810MB, 218812SB, 218812MB, 218814SB, 218814MB, 218811SB, 218811MB, 218816SB, 218816MB, 218818SB, 218818MB, 218820SB, 218820MB, 218823SB, 218823MB, 218825SB, 218825MB, 218828SB, 218828MB

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

Manufacturer: TECHNOLOGY S.R.L.
Manufacturer SRN: IT-MF-000035728
UDI-DI: 80537820605116
Basic UDI-DI: 80537820621883N
Reference: 218806SA
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 09:56

Manufacturer products View details