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275 device results listed.

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HbA1c Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041099118
Basic UDI-DI: B-62230041099118
Reference: 401 005
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 18.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

IVDR_67_TTN_DUB-C_C_KIT_A1c_E

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220505
Basic UDI-DI: 0405686900745VU
Reference: 11097536
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0943XFL

HbA1c Glycated Hemoglobin Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0943XFL
Basic UDI-DI: B-697994388Ir0943XFL
Reference: Ir094
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c) Twin A1c Analyzer

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182716356
Basic UDI-DI: B-62230182716356
Reference: D-858 001T
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) (Ion Exchange)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182715434
Basic UDI-DI: B-62230182715434
Reference: D-659 002
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) (Ion Exchange)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182715366
Basic UDI-DI: B-62230182715366
Reference: D-659 001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Plus

401 006

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041099040
Basic UDI-DI: B-62230041099040
Reference: 401 006
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c (HbA1c) Twin A1c Analyzer

602 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041080444
Basic UDI-DI: B-62230041080444
Reference: 602 001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:31

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Plus

401 003

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041077260
Basic UDI-DI: B-62230041077260
Reference: 401 003
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Kit (Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer)

401 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041047256
Basic UDI-DI: B-62230041047256
Reference: 401 001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c(HbA1c) Turbidimetric Immunoassay

602 000-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041025230
Basic UDI-DI: B-62230041025230
Reference: 602 000-I
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c(HbA1c) Turbidimetric Immunoassay

602 001-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041025162
Basic UDI-DI: B-62230041025162
Reference: 602 001-I
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Plus

401 001-M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041024318
Basic UDI-DI: B-62230041024318
Reference: 401 001-M
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Haemoglobin (GHb)

255 002

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041023014
Basic UDI-DI: B-62230041023014
Reference: 255 002
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Haemoglobin (GHb)

255 001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041022956
Basic UDI-DI: B-62230041022956
Reference: 255 001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Haemoglobin (GHb)

254 001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041022888
Basic UDI-DI: B-62230041022888
Reference: 254 001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Haemoglobin (GHb)

255 000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041022710
Basic UDI-DI: B-62230041022710
Reference: 255 000
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-22A4

Glycated albumin (GA) Assay Kit (Peroxidase Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-22A4
Basic UDI-DI: B-6-22A4
Reference: "REF: U84281040M, U84282040M, U84289040M, U84285020M, U84211020M, U84220040M"
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:12

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Enzymatic

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700804413
Basic UDI-DI: 37017008HBAE0134
Reference: HBAE-5M30
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 Enzymatic

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700804420
Basic UDI-DI: 37017008HBAE0134
Reference: HBAE-6M30
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