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299 device results listed.

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Monkeypox Virus Real-time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936402
Basic UDI-DI: B-06971225936402
Reference: GPCR130096
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go TSH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936365
Basic UDI-DI: B-06971225936365
Reference: FIA21025
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go TES Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936358
Basic UDI-DI: B-06971225936358
Reference: FIA47025
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go PROG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936334
Basic UDI-DI: B-06971225936334
Reference: FIA123024
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go CK-MB Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936327
Basic UDI-DI: B-06971225936327
Reference: FIA19025
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go β-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936310
Basic UDI-DI: B-06971225936310
Reference: FIA20025
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go VB12 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936303
Basic UDI-DI: B-06971225936303
Reference: FIA85024
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go T4 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936297
Basic UDI-DI: B-06971225936297
Reference: FIA23025
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go T3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936280
Basic UDI-DI: B-06971225936280
Reference: FIA22025
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go SAA Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936273
Basic UDI-DI: B-06971225936273
Reference: FIA39025
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go PRL Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936266
Basic UDI-DI: B-06971225936266
Reference: FIA45025
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go PCT Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936259
Basic UDI-DI: B-06971225936259
Reference: FIA07025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936211
Basic UDI-DI: B-06971225936211
Reference: CG125001
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 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo 25-OH-VD Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936204
Basic UDI-DI: B-06971225936204
Reference: CC038H
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo 25-OH-VD Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936198
Basic UDI-DI: B-06971225936198
Reference: CC038M
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo 25-OH-VD Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936181
Basic UDI-DI: B-06971225936181
Reference: CC038L
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo 25-OH-VD Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936167
Basic UDI-DI: B-06971225936167
Reference: KM38018
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo 25-OH-VD Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936150
Basic UDI-DI: B-06971225936150
Reference: KM38060
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

A1c Go HbA1c Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936020
Basic UDI-DI: B-06971225936020
Reference: AC01025
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo hs-cTnI Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935863
Basic UDI-DI: B-06971225935863
Reference: KM07018
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details