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08436601290151

CAP DEEP ACTION FOCUS

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

Manufacturer: Termosalud, S.L.
Manufacturer SRN: ES-MF-000019177
UDI-DI: 08436601290151
Basic UDI-DI: 843660129ZPCAPELFBS
Reference: AR00010348
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:54

Manufacturer products View details

08436601290144

CAP DEEP ACTION

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

Manufacturer: Termosalud, S.L.
Manufacturer SRN: ES-MF-000019177
UDI-DI: 08436601290144
Basic UDI-DI: 843660129ZPCAPELXE
Reference: AR00010346
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:54

Manufacturer products View details

08436601290137

RES DEEP ACTION FOCUS

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

Manufacturer: Termosalud, S.L.
Manufacturer SRN: ES-MF-000019177
UDI-DI: 08436601290137
Basic UDI-DI: 843660129ZPRESELFKW
Reference: AR00010349
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:54

Manufacturer products View details

Longitudinal electrode 14 mm Resistive

INTRACAVITARY ELECTRODES

Class IIaMDR 2017/745On the market

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251001288
Basic UDI-DI: 8434251A12D1D2Z00096
Reference: ELE0022INT
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

F2 fascia Long

ELECTRODES

Class IMDR 2017/745On the marketAnnex XVI applicableEMR

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251001257
Basic UDI-DI: 8434251A2D1D2Z0000JP
Reference: 279864MED/279864
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

Curve resistive handle with cable

HANDLES

Class IMDR 2017/745On the market

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251001165
Basic UDI-DI: 8434251A3D1D2Z0000KL
Reference: ACC0387/ACC0387MED
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

INDIBA PROIONIC® ACTIV CREAM

PROIONIC® CREAMS

Class IMDR 2017/745On the marketAnnex XVI applicableEMR

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251000380
Basic UDI-DI: 8434251A5D1D2Z0000ME
Reference: ACRE121
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

Activ CT9

RADIOFREQUENCY NS

Class IIaMDR 2017/745On the marketActive device

Manufacturer: INDIBA S.A.U.
Manufacturer SRN: ES-MF-000001243
UDI-DI: 08434251000069
Basic UDI-DI: 8434251D1Z00000000AW
Reference: ACT0309
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

Bi-one LifeTouchTherapy

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicableEMR

Manufacturer: Expo Italia S.r.L.
Manufacturer SRN: IT-MF-000033291
UDI-DI: 08056000870008
Basic UDI-DI: 805600087Bi-oneJA
Reference: DVC0003
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:03

Manufacturer products View details

NuEra Tight

NuEra Tight 1ch

Class IIbMDR 2017/745On the marketActive deviceAnnex XVI applicable

Manufacturer: BIOS Srl
Manufacturer SRN: IT-MF-000022514
UDI-DI: 08052049500302
Basic UDI-DI: 805204950SKRFD4
Reference: APMD145-1ch
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:12

Manufacturer products View details

ActivCellpen

Direct cold plasma therapy device

Class IIaMDR 2017/745Not intended for EU marketActive device

Manufacturer: Effectum Medical AG
Manufacturer SRN: CH-MF-000012474
UDI-DI: 07640255020397
Basic UDI-DI: 764025502ACT100WU
Reference: ACT-100.100
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: -
Authorised representative: MED-RAS GmbH Regulatory Affairs Service
Last updated: 03.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

Tixel Periorbital Handpiece

MPH00001

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Novoxel Ltd.
Manufacturer SRN: IL-MF-000008897
UDI-DI: 07290117520079
Basic UDI-DI: 729011752MPH00001CN
Reference: MPH00001
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Belgium
Authorised representative: mdi Europa GmbH
Last updated: 03.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

NeoGen 25mm Nozzle

Class INot specifiedOn the marketActive device

Manufacturer: Energist
Manufacturer SRN: GB-MF-000021765
UDI-DI: 15060440520201
Basic UDI-DI: 506044052NeoGen-NZ-001R8
Reference: 930-009
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: -
Authorised representative: Advena Limited
Last updated: 02.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Tixel Periorbital Handpiece

MPH00001

Class IIaMDR 2017/745Not intended for EU marketActive device

Manufacturer: Novoxel GmbH
Manufacturer SRN: DE-MF-000012740
UDI-DI: 04260755670071
Basic UDI-DI: 426075567MPH00001HL
Reference: MPH00001
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 23:12

Manufacturer products View details

Tixel Standard Handpiece

THLM0002

Class IIaMDR 2017/745Not intended for EU marketActive device

Manufacturer: Novoxel GmbH
Manufacturer SRN: DE-MF-000012740
UDI-DI: 04260755670026
Basic UDI-DI: 426075567THLM0002UT
Reference: THLM0002
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 23:12

Manufacturer products View details

Alma Harmony

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Alma Lasers GmbH
Manufacturer SRN: DE-MF-000006907
UDI-DI: 04252004600243
Basic UDI-DI: 42520046ALMAHARMONY2D
Reference: AAHG25102201BR0002
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:15

Manufacturer products View details

Alma Hybrid

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Alma Lasers GmbH
Manufacturer SRN: DE-MF-000006907
UDI-DI: 04252004600007
Basic UDI-DI: 42520046ALMAHYBRIDDW
Reference: AACO15061980BDRZ0001
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:15

Manufacturer products View details

Sublio light

Sublio Hyperionic Water Life

Class IMDR 2017/745On the marketActive device

Manufacturer: Involutech
Manufacturer SRN: FR-MF-000048056
UDI-DI: 03760431830009
Basic UDI-DI: 310643SUBLIOHYPERVR
Reference: SDT 114
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:20

Manufacturer products View details

Mitelier

Class IIIMDDOn the marketImplantableReprocessedSingle useSterile

Manufacturer: PRP Science Co., Ltd.
Manufacturer SRN: KR-MF-000014450
UDI-DI: 08800125100782
Basic UDI-DI: B-08800125100782
Reference: Not applicable
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Ireland
Authorised representative: Meridius Medical Europe Limited
Last updated: 01.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

Proluma

Class IIIMDDOn the marketImplantableReprocessedSingle useSterile

Manufacturer: PRP Science Co., Ltd.
Manufacturer SRN: KR-MF-000014450
UDI-DI: 08800125100744
Basic UDI-DI: B-08800125100744
Reference: Not applicable
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Ireland
Authorised representative: Meridius Medical Europe Limited
Last updated: 01.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details