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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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444 device results listed.

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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

Inreda

Class IIbNot specifiedOn the market

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897813452
Basic UDI-DI: 471094933APP00001EC
Reference: R0C065
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Inreda

HT510, HT510 single use

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897813407
Basic UDI-DI: 471094933CGM000109K
Reference: I0C069
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Syai

X1, M8

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: SYAI HEALTH TECHNOLOGY PTE. LTD.
Manufacturer SRN: SG-MF-000041645
UDI-DI: 08885021260006
Basic UDI-DI: 88850212601VJ
Reference: ST12024
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Italy
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 01.08.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

Hippo H1

Continuous glucose monitoring device

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: HIPPO MEDICAL PTE. LTD.
Manufacturer SRN: SG-MF-000044482
UDI-DI: 08881300792008
Basic UDI-DI: 8881300792H1KZ
Reference: H1EN
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Ireland
Authorised representative: PureCE B.V.
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoMen® iCan view Glucose Data Reader

iCGM-V3

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175024070
Basic UDI-DI: 6934175005A0003PR
Reference: MDA 0204
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 18:56

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Sinocare iCan

i3, o3

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175023936
Basic UDI-DI: 6934175005A0007PZ
Reference: N/A
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 18:56

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Sinocare iCan

i6, H6, i7, H7

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175014071
Basic UDI-DI: 6934175005A0005PV
Reference: N/A
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 18:56

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Sinocare iCan

i3, o3

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175014019
Basic UDI-DI: 6934175005A0001PM
Reference: N/A
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Libre

Libre App

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Abbott Diabetes Care Ltd
Manufacturer SRN: GB-MF-000029309
UDI-DI: 05021791010554
Basic UDI-DI: 5021791LAP0001BM
Reference: 79088-01
EMDN: Z1204011501
EMDN description: NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Denmark
Authorised representative: Abbott B.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

FreeStyle Libre 3 Plus Continuous Glucose Monitoring System

FreeStyle Libre 3 Continuous Glucose Monitoring System (Sensor Kit) / FreeStyle Libre 3 Plus Continuous Glucose Monitoring System (Sensor Kit) / Instinct sensor / Instinct Go sensor

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Abbott Diabetes Care Ltd
Manufacturer SRN: GB-MF-000029309
UDI-DI: 05021791007257
Basic UDI-DI: 5021791FLS0003E3
Reference: 78788-01
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Belgium
Authorised representative: Abbott B.V.
Last updated: 31.07.2026 07:53

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FreeStyle LibreLink app

FreeStyle LibreLink App

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Abbott Diabetes Care Ltd
Manufacturer SRN: GB-MF-000029309
UDI-DI: 05021791001811
Basic UDI-DI: 5021791LLA0001AX
Reference: 71889-01
EMDN: Z1204011501
EMDN description: NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Spain
Authorised representative: Abbott B.V.
Last updated: 31.07.2026 07:53

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FreeStyle Libre 2 Flash Glucose Monitoring System

FreeStyle Libre 2 Flash Glucose Monitoring System (Reader Kit)

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Abbott Diabetes Care Ltd
Manufacturer SRN: GB-MF-000029309
UDI-DI: 05021791001392
Basic UDI-DI: 5021791FLR0002DN
Reference: 71956-01
EMDN: Z1204011501
EMDN description: NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Belgium
Authorised representative: Abbott B.V.
Last updated: 31.07.2026 07:53

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

RIGHTEST iFree 2

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897813124
Basic UDI-DI: 471094933CGM000109K
Reference: R0C09A
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST iFree2

HS510

Class IIbMDR 2017/745On the marketMeasuring functionSingle useSterile

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897812936
Basic UDI-DI: 471094933CGM00009A2
Reference: R0C066
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: 30.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST iFree

GP922

Class IIbMDR 2017/745On the marketMeasuring function

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: 04719897810857
Basic UDI-DI: 471094933APP00001EC
Reference: R0C014
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

SIBIONICS GS3-R Continuous Glucose Monitoring System

GS3

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Shenzhen SiSensing Co., Ltd.
Manufacturer SRN: CN-MF-000017945
UDI-DI: 06972831644002
Basic UDI-DI: 697283164CGMGS3LQ
Reference: GS3-R
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

SIBIONICS GS3-R Continuous Glucose Monitoring System

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Shenzhen SiSensing Co., Ltd.
Manufacturer SRN: CN-MF-000017945
UDI-DI: 06972831644019
Basic UDI-DI: 697283164CGMGS3LQ
Reference: GS3-R
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details