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41 device results listed.

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Glycosylated Hemoglobin (HbA1c) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)

25 tests/kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698403441
Basic UDI-DI: B-06977698403441
Reference: GKPD066
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142615

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142615
Basic UDI-DI: B-06977194142615
Reference: HR0530003
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142608

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142608
Basic UDI-DI: B-06977194142608
Reference: HR0530002
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142592

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142592
Basic UDI-DI: B-06977194142592
Reference: HR0530001
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

06977194141564

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194141564
Basic UDI-DI: B-06977194141564
Reference: HR0200301
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1C) Test Kit (Fluorescence immunochromatography method)

50 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750442
Basic UDI-DI: B-06976374750442
Reference: 50 tests / kit（DR016-2）
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1C) Test Kit (Fluorescence immunochromatography method)

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750435
Basic UDI-DI: B-06976374750435
Reference: 25 tests / kit（DR016-4）
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1C) Test Kit (Fluorescence immunochromatography method)

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750428
Basic UDI-DI: B-06976374750428
Reference: 20 tests / kit（DR016-1）
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Haemoglobin A1c（Immunochromatographic Assay）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490527
Basic UDI-DI: B-06975068490527
Reference: CP024.B1
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000888
Basic UDI-DI: B-06973841000888
Reference: BA0040
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:38

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

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983440
Basic UDI-DI: B-06970291983440
Reference: ZK411CY
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983433
Basic UDI-DI: B-06970291983433
Reference: ZK411BY
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334821984
Basic UDI-DI: B-06950334821984
Reference: 52026278
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

06950334804543

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804543
Basic UDI-DI: B-06950334804543
Reference: 52026008
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Kit (Enzymatic Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595752120
Basic UDI-DI: B-06936595752120
Reference: MJ420Y
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750294
Basic UDI-DI: B-06936595750294
Reference: MJ411Y
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595705980
Basic UDI-DI: B-06936595705980
Reference: ZK420Y1
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:52

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: 06934175002481
Basic UDI-DI: B-06934175002481
Reference: 12600137
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175001385
Basic UDI-DI: B-06934175001385
Reference: 12600153
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details