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

Last updated

22.09.2026 20:14

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164 device results listed.

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Safe AQ pro I

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175016594
Basic UDI-DI: B-06934175016594
Reference: 5Y001DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Voice

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175012480
Basic UDI-DI: B-06934175012480
Reference: 2K003DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Neutrophil gelatinase-associated lipocalin Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009442
Basic UDI-DI: B-06934175009442
Reference: 12600551
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Lipoprotein-associated Phospholipase A2 Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009435
Basic UDI-DI: B-06934175009435
Reference: 12600550
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

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Serum amyloid A Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009428
Basic UDI-DI: B-06934175009428
Reference: 12600549
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

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Heart-type fatty acid-binding protein Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009411
Basic UDI-DI: B-06934175009411
Reference: 12600548
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

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Pepsinogen I/Pepsinogen II Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009398
Basic UDI-DI: B-06934175009398
Reference: 12600550
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009381
Basic UDI-DI: B-06934175009381
Reference: 12600545
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

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C-Reactive Protein/Anti-streptolysin O/Rheumatoid Factor Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009350
Basic UDI-DI: B-06934175009350
Reference: 12600542
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

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Immunoglobulin (IgA/IgG/IgM)Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009374
Basic UDI-DI: B-06934175009374
Reference: 12600544
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Reagent kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009343
Basic UDI-DI: B-06934175009343
Reference: 12600541
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte (CO2/Mg/P/Fe) Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009336
Basic UDI-DI: B-06934175009336
Reference: 12600540
EMDN: W01010302
EMDN description: BICARBONATE
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

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Portable Automatic Multi-Function Analyzer (iCARE-1300)

iCARE-1300

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 16934175044457
Basic UDI-DI: 6934175002A0002NG
Reference: 10500077
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution Level 1

Level 1

IVD Class CIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175030446
Basic UDI-DI: 6934175001C0102NW
Reference: 1A003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Safety summary (SSCP/SSP): NPI052-SR-101 · Rev. A.2
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

H101, H102

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010721
Basic UDI-DI: 6934175001B0520P9
Reference: 7C005
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

H102 Air ，H101

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010684
Basic UDI-DI: 6934175001A0620P3
Reference: 7C001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Level 1, Level 2

IVD Class BIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009930
Basic UDI-DI: 6934175001C0501PG
Reference: REF 8C001, REF 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

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

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent Kit

Hematology Reagent Kit

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175046249
Basic UDI-DI: 6934175002B0030NY
Reference: 12600777
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details