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FreeStyle Libre 2 Flash Glucose Monitoring System

FreeStyle Libre 2 Flash Glucose Monitoring System (Sensor Kit) / FreeStyle Libre 2 Plus Flash Glucose Monitoring System (Sensor Kit) / FreeStyle Libre Select Continuous Glucose Monitoring Sensor

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Abbott Diabetes Care Ltd
Manufacturer SRN: GB-MF-000029309
UDI-DI: 05021791000876
Basic UDI-DI: 5021791FLS0002DZ
Reference: 71988-01
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Germany
Authorised representative: Abbott B.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Feetsee

SW v1.1

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: UAB DIABETIS
Manufacturer SRN: LT-MF-000041929
UDI-DI: 04779060790102
Basic UDI-DI: 477906079FE.-1.A6E
Reference: REF_TEST
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:08

Manufacturer products 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: 04719872710035
Basic UDI-DI: 47198727100007L
Reference: MiiS Horus+ Scope DSC 200P
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DDC series

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872713029
Basic UDI-DI: 471987271300089
Reference: MiiS Horus Scope DDC 200
EMDN: Z12040108
EMDN description: DERMATOSCOPES
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST iFree 2

HT510

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897812943
Basic UDI-DI: 471094933CGM000109K
Reference: R0C068, R0C069, R0C06A
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS

SA 1

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872717034
Basic UDI-DI: 471987271700095
Reference: Model: SA 1
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

MPD series

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872713036
Basic UDI-DI: 47198727130078P
Reference: MPD 100
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

MiiS Horus Scope

DDC series

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872713012
Basic UDI-DI: 471987271300089
Reference: MiiS Horus Scope DDC 100
EMDN: Z12040108
EMDN description: DERMATOSCOPES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:36

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: 04719872710011
Basic UDI-DI: 47198727100007L
Reference: MiiS Horus Scope DSC 100
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

04270004355819

Mediq

Class IMDR 2017/745On the marketActive device

Manufacturer: SYNAPTIQ TECHNOLOGIES SRL
Manufacturer SRN: RO-MF-000038617
UDI-DI: 04270004355819
Basic UDI-DI: 42700043558MediqOS4W
Reference: v1.0.0
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 05:47

Manufacturer products View details

Scaut

Class IMDR 2017/745On the marketActive device

Manufacturer: DocCheck Steam GmbH
Manufacturer SRN: DE-MF-000050235
UDI-DI: 04262560080175
Basic UDI-DI: 426256008103842BN
Reference: 103842.0
EMDN: Z12040118
EMDN description: VIDEO DERMATOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:43

Manufacturer products View details

04260744820548

Ada Assess

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ada Health GmbH
Manufacturer SRN: DE-MF-000009202
UDI-DI: 04260744820548
Basic UDI-DI: 426074482AdaAssessPW
Reference: not applicable
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

SYMC

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DOCYET GmbH
Manufacturer SRN: DE-MF-000007275
UDI-DI: 04262382550009
Basic UDI-DI: 426238255SYMCFB
Reference: 04262382550009
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

04260744820531

Ada Assess

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ada Health GmbH
Manufacturer SRN: DE-MF-000009202
UDI-DI: 04260744820531
Basic UDI-DI: 426074482AdaAssessPW
Reference: not applicable
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:22

Manufacturer products View details

Clinic WinData

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXUS / E&L GmbH
Manufacturer SRN: DE-MF-000006906
UDI-DI: 04260721060073
Basic UDI-DI: 426072106CWDIIa5T
Reference: 09.14.xx
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:22

Manufacturer products View details

04260744820524

Ada Assess

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Ada Health GmbH
Manufacturer SRN: DE-MF-000009202
UDI-DI: 04260744820524
Basic UDI-DI: 426074482AdaAssessPW
Reference: not applicable
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

Clinic WinData

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXUS / E&L GmbH
Manufacturer SRN: DE-MF-000006906
UDI-DI: 04260721060066
Basic UDI-DI: 426072106CWDIIa5T
Reference: 09.13.xx
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

NEXUS / Scoring

Class IIaMDR 2017/745On the marketActive device

Manufacturer: NEXUS / CMC GmbH
Manufacturer SRN: DE-MF-000007980
UDI-DI: 04260686517056
Basic UDI-DI: 426068651700BM
Reference: 26.2
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:13

Manufacturer products View details

EZ Dop K1

EZ-Dop Series

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Compumedics Germany GmbH
Manufacturer SRN: DE-MF-000005586
UDI-DI: 04260493312554
Basic UDI-DI: 4260493319000VL
Reference: 9000
EMDN: Z12040111
EMDN description: BLOOD FLOW METERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:02

Manufacturer products View details

Multi-Dop® T

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Compumedics Germany GmbH
Manufacturer SRN: DE-MF-000005586
UDI-DI: 04260493310062
Basic UDI-DI: 4260493318000VD
Reference: 8000
EMDN: Z12040111
EMDN description: BLOOD FLOW METERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:02

Manufacturer products View details