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275 device results listed.

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HbA1c Enzymatic

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700804437
Basic UDI-DI: 37017008HBAE0134
Reference: HBAE-7050
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

HbA1c

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821311
Basic UDI-DI: 37017008HBAC002Q
Reference: HBAC-5224
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

HbA1c

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821328
Basic UDI-DI: 37017008HBAC002Q
Reference: HBAC-6076
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

HbA1c

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821335
Basic UDI-DI: 37017008HBAC002Q
Reference: HBAC-6004
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

HbA1c

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821342
Basic UDI-DI: 37017008HBAC002Q
Reference: HBAC-7225
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

D-K91201-064C

HbA1c-BP

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-064C
Basic UDI-DI: B-K91201-064C
Reference: /
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-005P7

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

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-005P7
Basic UDI-DI: B-K90411-005P7
Reference: /
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Direct Hemoglobin HbA1c

I0250

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0250NF
Basic UDI-DI: B-I0250NF
Reference: I0250
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:03

Manufacturer products View details

Glycohemoglobin A1c Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HbA1c601Q8
Basic UDI-DI: B-HbA1c601Q8
Reference: HbA1c6011Y, HbA1c6012Y, HbA1c6013Y, HbA1c6014Y, HbA1c6015Y, HbA1c6011N, HbA1c6012N, HbA1c6013N, HbA1c6014N, HbA1c6015N
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Glycohemoglobin A1c Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HbA1c-S601EZ
Basic UDI-DI: B-HbA1c-S601EZ
Reference: HbA1c-S6011Y,HbA1c-S6012Y,HbA1c-S6013Y,HbA1c-S6014Y,HbA1c-S6015Y,HbA1c-S6011N,HbA1c-S6012N,HbA1c-S6013N,HbA1c-S6014N
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050110464

Glycosylated Hemoglobin A1c (HbA1c)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050110464
Basic UDI-DI: B-ECH050110464
Reference: ECH0501104
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01051045C

Glycosylated Hemoglobin A1c (HbA1c)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01051045C
Basic UDI-DI: B-ECH01051045C
Reference: ECH0105104
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2599001FB

Glycated Hemoglobin A1c (HPLC) Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2599001FB
Basic UDI-DI: B-BL2599001FB
Reference: BL2599001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2590001DC

Glycated Hemoglobin A1c (HPLC) Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2590001DC
Basic UDI-DI: B-BL2590001DC
Reference: BL2590001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2584001DV

Glycated Hemoglobin A1c (HPLC) Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2584001DV
Basic UDI-DI: B-BL2584001DV
Reference: BL2584001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2583001DN

Glycated Hemoglobin A1c (HPLC) Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2583001DN
Basic UDI-DI: B-BL2583001DN
Reference: BL2583001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2582001DF

Glycated Hemoglobin A1c (HPLC)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2582001DF
Basic UDI-DI: B-BL2582001DF
Reference: BL2582001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2581001D8

Glycated Hemoglobin A1c (HPLC)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2581001D8
Basic UDI-DI: B-BL2581001D8
Reference: BL2581001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2578001EE

Glycated Hemoglobin A1c (HPLC) Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2578001EE
Basic UDI-DI: B-BL2578001EE
Reference: BL2578001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL2573001DB

Glycated Hemoglobin A1c (HPLC) Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2573001DB
Basic UDI-DI: B-BL2573001DB
Reference: BL2573001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details