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326 device results listed.

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Dimension Vista A1C Kit

DX_LS_LEGACY_00630414006666

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414006666
Basic UDI-DI: B-00630414006666
Reference: 10720885
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061684
Basic UDI-DI: B-06974524061684
Reference: HCLIA15105
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c ) Turbidimetric Immunoassay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458602001IT3
Basic UDI-DI: B-G458602001IT3
Reference: 602 001-I
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 09.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c ) Turbidimetric Immunoassay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458602000IQ3
Basic UDI-DI: B-G458602000IQ3
Reference: 602 000-I
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 09.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer HbA1c kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458401002XH
Basic UDI-DI: B-G458401002XH
Reference: 401 002
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 09.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer HbA1c kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458401001VH
Basic UDI-DI: B-G458401001VH
Reference: 401 001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 09.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Turbidimetric Immunoassay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G45813202104Z
Basic UDI-DI: B-G45813202104Z
Reference: 132 02 10
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 09.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (GHb) (Ion Exchange Resin method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458131150038G
Basic UDI-DI: B-G458131150038G
Reference: 131 15 003
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 09.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1: 1x60mL, R2: 1x20mL, Diluent: 7mL, Calibration sample: 5x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238475
Basic UDI-DI: B-06942202238475
Reference: 3016181
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control Normal

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816956
Basic UDI-DI: 6438153BU00026BK
Reference: 981695
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

Manufacturer products View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

Control: 2×1mL, Diluent: 7mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261633
Basic UDI-DI: B-06942202261633
Reference: 3023075
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

Calibration sample: 5×1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261626
Basic UDI-DI: B-06942202261626
Reference: 232021202009
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1: 1x60mL, R2: 1x20mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260032
Basic UDI-DI: B-06942202260032
Reference: 3016184
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:2×15mL , R2-A：1×0.5mL, R2-B：1×9.5mL, Lyse：2×50mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260025
Basic UDI-DI: B-06942202260025
Reference: 3012544
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:2×15mL , R2-A：1×0.5mL, R2-B：1×9.5mL, Lyse：2×50mL, Diluent: 5mL, Calibration sample: 5x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260018
Basic UDI-DI: B-06942202260018
Reference: 3014894
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse: 2×50mL ,Diluent:7mL,Calibration sample: 5x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260001
Basic UDI-DI: B-06942202260001
Reference: 3016543
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL, Diluent:7mL,Calibration sample: 5x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202259999
Basic UDI-DI: B-06942202259999
Reference: 3021169
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL ,Lyse:2×50mL, Diluent:7mL,Calibration sample: 5x1mL,

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202259982
Basic UDI-DI: B-06942202259982
Reference: 3021159
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL ,Lyse:2×50mL, Diluent:7mL,1x20mL, Calibration sample: 5x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202259975
Basic UDI-DI: B-06942202259975
Reference: 3016511
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1: 1x60mL, R2: 1x20mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202246753
Basic UDI-DI: B-06942202246753
Reference: 3012188
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details