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InnoSpire Go LiteTouch Large Mask

InnoSpire Go

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000541
Basic UDI-DI: B-00383730000541
Reference: 1127875
EMDN: Z12040210
EMDN description: ULTRASONIC NEBULISERS
First on market country: Belgium
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 05.08.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

InnoSpire Go EU1/ROW

InnoSpire Go

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000534
Basic UDI-DI: B-00383730000534
Reference: 1126593
EMDN: Z12040210
EMDN description: ULTRASONIC NEBULISERS
First on market country: Belgium
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 05.08.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

09180002980218

Health Check

Class IMDR 2017/745On the marketActive device

Manufacturer: XUND Solutions GmbH
Manufacturer SRN: AT-MF-000014461
UDI-DI: 09180002980218
Basic UDI-DI: 918000298HealthCheckQZ
Reference: Health Check
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 22:58

Manufacturer products View details

flex transducer array, white

Class IIbMDR 2017/745No longer on the marketActive deviceSingle useSterile

Manufacturer: Novocure GmbH
Manufacturer SRN: CH-MF-000029002
UDI-DI: 07290107984492
Basic UDI-DI: 0729010798394X2
Reference: IHEP9020WEU
EMDN: Z12040285
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

flex transducer array, black

IHEP9020B, IHEP9020W

Class IIbMDR 2017/745No longer on the marketActive deviceSingle useSterile

Manufacturer: Novocure GmbH
Manufacturer SRN: CH-MF-000029002
UDI-DI: 07290107984485
Basic UDI-DI: 0729010798394X2
Reference: IHEP9020BEU
EMDN: Z12040285
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

SonoTTTM aQuila I

aQuila

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: em-tec GmbH
Manufacturer SRN: DE-MF-000008066
UDI-DI: 40621140005946
Basic UDI-DI: 4062114000587M6
Reference: 13858
EMDN: Z12040111
EMDN description: BLOOD FLOW METERS
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

07290016586183

triLift

Class IIbMDDOn the market

Manufacturer: Pollogen Ltd
Manufacturer SRN: IL-MF-000031034
UDI-DI: 07290016586183
Basic UDI-DI: B-07290016586183
Reference: 30020000
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

07290016586473

OptiLift

Class IIbMDDOn the market

Manufacturer: Pollogen Ltd
Manufacturer SRN: IL-MF-000031034
UDI-DI: 07290016586473
Basic UDI-DI: B-07290016586473
Reference: 35000200BK
EMDN: Z12040280
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

09180002980201

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: XUND Solutions GmbH
Manufacturer SRN: AT-MF-000014461
UDI-DI: 09180002980201
Basic UDI-DI: 918000298HealthCheckQZ
Reference: Health Check
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

08720689018838

Philips Lumea

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

Manufacturer: Philips Consumer Lifestyle B.V.
Manufacturer SRN: NL-MF-000001693
UDI-DI: 08720689018838
Basic UDI-DI: 8710103BM1173AG
Reference: BRI937
EMDN: Z12040201
EMDN description: PHOTOEPILATION EQUIPMENT
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 22:47

Manufacturer products View details

LuMon™ Connector 2.0

LuMon™ Connector

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Sentec AG
Manufacturer SRN: CH-MF-000008058
UDI-DI: 07640121881763
Basic UDI-DI: 764012188LMCJE
Reference: 1ST120-100
EMDN: Z120499
EMDN description: GENERAL MEDICINE INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sentec GmbH
Last updated: 04.08.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

LuMon™ Monitor

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: Sentec AG
Manufacturer SRN: CH-MF-000008058
UDI-DI: 07640121881756
Basic UDI-DI: 764012188LMMK2
Reference: 2ST200-100
EMDN: Z120499
EMDN description: GENERAL MEDICINE INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sentec GmbH
Last updated: 04.08.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Inreda

Class IIbNot specifiedOn the market

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897813445
Basic UDI-DI: 471094933APP00001EC
Reference: I0C064
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Inreda

HS312

Class IIbMDR 2017/745On the marketMeasuring functionSingle useSterile

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897812295
Basic UDI-DI: 471094933CGM000079W
Reference: I0C060
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DSC series

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872710073
Basic UDI-DI: 47198727100007L
Reference: MiiS Horus Scope DSC 300P
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Une Minute Pour mes Reins

1 Minute Pour mes Reins (MPR)

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: NEWCARD
Manufacturer SRN: FR-MF-000029884
UDI-DI: 03770034348030
Basic UDI-DI: 3770034348MPR7E
Reference: MPR-PS-ALL
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 04.08.2026 21:12

Manufacturer products View details

Vidal Sécurisation FR

VIDAL Sécurisation

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: VIDAL FRANCE
Manufacturer SRN: FR-MF-000004612
UDI-DI: 03666075005349
Basic UDI-DI: 3666075VSECU000001FS
Reference: 2025.09
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 04.08.2026 21:04

Manufacturer products View details

Shark CryoGlow

CryoGlow

Class IIaMDR 2017/745On the marketActive device

Manufacturer: SharkNinja Operating LLC
Manufacturer SRN: US-MF-000048207
UDI-DI: 06223563057302
Basic UDI-DI: 0622356FW300JA
Reference: FW313EU
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

Exceed

Microneedling Device MN1

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MT.DERM GmbH
Manufacturer SRN: DE-MF-000005784
UDI-DI: +EMTDAD61MP0
Basic UDI-DI: ++EMTDMN1HM
Reference: AD61MP
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 20:53

Manufacturer products View details

SONALLEVE MR-HIFU V2 ACHIEVA 1.5T

SONALLEVE MR-HIFU

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Profound Medical Inc.
Manufacturer SRN: CA-MF-000028761
UDI-DI: 07540281000236
Basic UDI-DI: 75402810200097
Reference: 451000080766
EMDN: Z1204021501
EMDN description: MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.08.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details