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79 device results listed.

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Nephstar HbA1c Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932190
Basic UDI-DI: B-06971225932190
Reference: DK072
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

Nephstar Plus HbA1c Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932206
Basic UDI-DI: B-06971225932206
Reference: NP72025
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo HbA1c Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931896
Basic UDI-DI: B-06971225931896
Reference: OP71050
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go HbA1c Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931193
Basic UDI-DI: B-06971225931193
Reference: FIA24025
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

GPP-100 HbA1c Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930479
Basic UDI-DI: B-06971225930479
Reference: GP72020
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807165086QL
Basic UDI-DI: B-000012807165086QL
Reference: HWTS-OT091
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500058
Basic UDI-DI: 697518250P140015Z
Reference: P14001
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751645

Glycosylated Hemoglobin Rapid Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751645
Basic UDI-DI: B-06970664751645
Reference: 25Tests/Kit
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)