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299 device results listed.

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lambda-FLC Control Level 2

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936969
Basic UDI-DI: B-06971225936969
Reference: DM093H
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152447
Basic UDI-DI: B-06977125152447
Reference: GHDBZ
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
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 Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152430
Basic UDI-DI: B-06977125152430
Reference: GHDDM2
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
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 Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152423
Basic UDI-DI: B-06977125152423
Reference: GHDDM1
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
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: 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 (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152393
Basic UDI-DI: B-06977125152393
Reference: GHB200
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
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 (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152386
Basic UDI-DI: B-06977125152386
Reference: GHB100
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
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

Kemilo PRL Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939878
Basic UDI-DI: B-06971225939878
Reference: CC030H
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo PRL Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939861
Basic UDI-DI: B-06971225939861
Reference: CC030M
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo PRL Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939854
Basic UDI-DI: B-06971225939854
Reference: CC030L
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo LH Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939847
Basic UDI-DI: B-06971225939847
Reference: CC027L
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo LH Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939830
Basic UDI-DI: B-06971225939830
Reference: CC027M
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo LH Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939823
Basic UDI-DI: B-06971225939823
Reference: CC027H
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo FSH Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939816
Basic UDI-DI: B-06971225939816
Reference: CC025H
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo FSH Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939809
Basic UDI-DI: B-06971225939809
Reference: CC025M
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo PROG Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939786
Basic UDI-DI: B-06971225939786
Reference: CC008M
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo PROG Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939779
Basic UDI-DI: B-06971225939779
Reference: CC008L
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo FSH Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939793
Basic UDI-DI: B-06971225939793
Reference: CC025L
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo AMH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939762
Basic UDI-DI: B-06971225939762
Reference: KM32060
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details