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69 device results listed.

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Hemoglobin

HB011

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101254
Basic UDI-DI: B-05404035101254
Reference: HB011
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

Hemoglobin A1c Eluent A

105-048455-00/105-048453-00/105-048454-00/105-048464-00

IVD Class AIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053088947
Basic UDI-DI: 69449040AB700001945
Reference: 105-048453-00
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent D

400 mL, 800 mL, 1600 mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066288
Basic UDI-DI: 69703416803202023HJ
Reference: 0320203007
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent C

400 mL, 800 mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066165
Basic UDI-DI: 69703416803202022HG
Reference: 0320202905
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent B

400 mL, 800 mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066141
Basic UDI-DI: 69703416803202021HE
Reference: 0320202805
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent A

400 mL, 800 mL, 1600 mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066127
Basic UDI-DI: 69703416803202020HC
Reference: 0320202707
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Assay Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152416
Basic UDI-DI: B-06977125152416
Reference: GHD200
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Assay Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152409
Basic UDI-DI: B-06977125152409
Reference: GHD100
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225572
Basic UDI-DI: B-06975424225572
Reference: DL233701C
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223868

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223868
Basic UDI-DI: B-06975424223868
Reference: DL233706
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Assay Kit (Fluorescence Immunoassay)

20T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424221765
Basic UDI-DI: B-06975424221765
Reference: 20T
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591401
Basic UDI-DI: B-06974464591401
Reference: 5257C4X025
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

91200176932606

HEMDETECT®50 x 3 TRISLIDES

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: DIPRO med GmbH
Manufacturer SRN: AT-MF-000024589
UDI-DI: 91200176932606
Basic UDI-DI: 912001769D596050JE
Reference: D596050
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 03.07.2026 23:50

Manufacturer products View details

HEMDETECT® Entwickler

HEMDETECT® Developer

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: DIPRO med GmbH
Manufacturer SRN: AT-MF-000024589
UDI-DI: 91200176932538
Basic UDI-DI: 912001769D596020J5
Reference: D596020
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 03.07.2026 23:50

Manufacturer products View details

Eluent B

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066158
Basic UDI-DI: 69703416803202021HE
Reference: 0320202806
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent B

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066134
Basic UDI-DI: 69703416803202020HC
Reference: 0320202708
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent C

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066172
Basic UDI-DI: 69703416803202022HG
Reference: 0320202906
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Eluent D

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984066295
Basic UDI-DI: 69703416803202023HJ
Reference: 0320203008
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

GHgb-Lyse

Lyse-G

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337851867
Basic UDI-DI: 697233785GHgbLyse009BZ
Reference: 60104
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Eluent

Eluent 1

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377305807
Basic UDI-DI: 697049309W01030000025A6
Reference: XQ-0105-02
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details