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299 device results listed.

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Hemolysis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939045
Basic UDI-DI: B-06971225939045
Reference: GHL4000
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Elution Buffer C

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939038
Basic UDI-DI: B-06971225939038
Reference: GH3800
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Elution Buffer C

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939021
Basic UDI-DI: B-06971225939021
Reference: GH3400
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Elution Buffer B

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939014
Basic UDI-DI: B-06971225939014
Reference: GH2400
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Elution Buffer B

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939007
Basic UDI-DI: B-06971225939007
Reference: GH2800
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Elution Buffer A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938994
Basic UDI-DI: B-06971225938994
Reference: GH1400
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Elution Buffer A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938987
Basic UDI-DI: B-06971225938987
Reference: GH1800
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo D-Dimer Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938758
Basic UDI-DI: B-06971225938758
Reference: CC010L
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Nephstar Plus bCRP Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938819
Basic UDI-DI: B-06971225938819
Reference: NP51102
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo D-Dimer Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938765
Basic UDI-DI: B-06971225938765
Reference: CC010H
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Lp(a) Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938437
Basic UDI-DI: B-06971225938437
Reference: DM043
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B & RSV Antigen Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938413
Basic UDI-DI: B-06971225938413
Reference: CG127025
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B & RSV Antigen Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938406
Basic UDI-DI: B-06971225938406
Reference: CG127001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

A1c Go HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937966
Basic UDI-DI: B-06971225937966
Reference: HBDMAC2
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

A1c Go HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937959
Basic UDI-DI: B-06971225937959
Reference: HBDMAC1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo CRP Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937942
Basic UDI-DI: B-06971225937942
Reference: OP22200
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo IgG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937935
Basic UDI-DI: B-06971225937935
Reference: OP04100
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

lambda-FLC Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937454
Basic UDI-DI: B-06971225937454
Reference: BZ093
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

kappa-FLC Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937447
Basic UDI-DI: B-06971225937447
Reference: BZ092
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo Lambda-FLC Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937430
Basic UDI-DI: B-06971225937430
Reference: OP93050
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details