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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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164 device results listed.

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D-01B0101Y3

Safe-Accu

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0101Y3
Basic UDI-DI: B-01B0101Y3
Reference: 1N003
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

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D-01A0111XT

Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ max Ⅱ, Safe AQ max Ⅲ

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0111XT
Basic UDI-DI: B-01A0111XT
Reference: 5Y001, 5Z001, 6A001, 6B001, 6C001, 6D001
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

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D-01A0206Y7

Safe AQ UG

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0206Y7
Basic UDI-DI: B-01A0206Y7
Reference: 1V001
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

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D-01A0104XW

Safe AQ Voice; Safe AQ Smart; Safe AQ Air

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0104XW
Basic UDI-DI: B-01A0104XW
Reference: 2J003; 2J004; 2K002; 2K003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-01A0103XU

Safe AQ Angel

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0103XU
Basic UDI-DI: B-01A0103XU
Reference: 2B001
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

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D-01A0102XS

Safe-Accu 2

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0102XS
Basic UDI-DI: B-01A0102XS
Reference: 5D001
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-01A0101XQ

Safe-Accu

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0101XQ
Basic UDI-DI: B-01A0101XQ
Reference: 1N002
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

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GlucoMen® iCan

i3, o3

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175004157
Basic UDI-DI: 6934175005A0001PM
Reference: 58610
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 09:57

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Sinocare iCan

i6, H6, i7, H7

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175006502
Basic UDI-DI: 6934175005A0005PV
Reference: 10600231
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

PCH-50

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175006137
Basic UDI-DI: 6934175004A0001P8
Reference: 10500022
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 09:57

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Sinocare iCan® view Glucose Data Reader

iCGM-V3

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175001903
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: 02.07.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Automatic Multi-Function Analyzer (iCARE-1300)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 16934175049797
Basic UDI-DI: 6934175002A0002NG
Reference: 10500075
EMDN: W02010399
EMDN description: INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoMen®

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175099511
Basic UDI-DI: 6934175005A0002PP
Reference: N/A
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoMen®

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175099528
Basic UDI-DI: 6934175005A0002PP
Reference: N/A
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD generalNot specifiedNo longer on the market

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009329
Basic UDI-DI: B-06934175009329
Reference: 12600539
EMDN: W01010309
EMDN description: SODIUM
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ max Ⅲ

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175008452
Basic UDI-DI: B-06934175008452
Reference: 6D006DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ max Ⅲ

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175008445
Basic UDI-DI: B-06934175008445
Reference: 6D005DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoMen® iCan view Glucose Data Reader

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175007608
Basic UDI-DI: 6934175005A0003PR
Reference: MDA 0204
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare iCan® view Glucose Data Reader

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175007554
Basic UDI-DI: 6934175005A0003PR
Reference: MDA 0204
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare iCan® view Glucose Data Reader

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175007516
Basic UDI-DI: 6934175005A0003PR
Reference: MDA 0204
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details