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133 device results listed.

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06975278861179

Phosphorylation of Tau217 (p-Tau217) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861179
Basic UDI-DI: B-06975278861179
Reference: XRDL063A105OS
EMDN: W0102019017
EMDN description: PHOSPHORYLATED TAU (PTAU)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:07

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861162

Glial Fibrillary Acidic Protein (GFAP) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861162
Basic UDI-DI: B-06975278861162
Reference: XRDL061A120OS
EMDN: W01021701
EMDN description: GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861155

Glial Fibrillary Acidic Protein (GFAP) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861155
Basic UDI-DI: B-06975278861155
Reference: XRDL061A105OS
EMDN: W01021701
EMDN description: GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861148

Human β Amyloid 1-42 (Aβ1-42) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861148
Basic UDI-DI: B-06975278861148
Reference: XRDL059A120OS
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861131

Human β Amyloid 1-42 (Aβ1-42) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861131
Basic UDI-DI: B-06975278861131
Reference: XRDL059A105OS
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861124

Alpha-fetoprotein Lens Culinaris Agglutinin 3 (AFP-L3) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861124
Basic UDI-DI: B-06975278861124
Reference: XRDL058A120OS
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861117

Alpha-fetoprotein Lens Culinaris Agglutinin 3 (AFP-L3) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861117
Basic UDI-DI: B-06975278861117
Reference: XRDL058A105OS
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861100

Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKA-Ⅱ) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861100
Basic UDI-DI: B-06975278861100
Reference: XRDL054A120OS
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861094

Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKA-Ⅱ) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861094
Basic UDI-DI: B-06975278861094
Reference: XRDL054A105OS
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861087

Human Epididymis Protein 4 (HE4) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861087
Basic UDI-DI: B-06975278861087
Reference: XRDL052A120OS
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861070

Human Epididymis Protein 4 (HE4) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861070
Basic UDI-DI: B-06975278861070
Reference: XRDL052A105OS
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861063

Neuron-Speciﬁc Enolase (NSE) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861063
Basic UDI-DI: B-06975278861063
Reference: XRDL043A120OS
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861056

Neuron-Speciﬁc Enolase (NSE) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861056
Basic UDI-DI: B-06975278861056
Reference: XRDL043A105OS
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861049

Folic Acid (FA) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861049
Basic UDI-DI: B-06975278861049
Reference: XRDL042A120OS
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861032

Folic Acid (FA) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861032
Basic UDI-DI: B-06975278861032
Reference: XRDL042A105OS
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861025

TB Specific Cellular Immune Response (TB-IGRA) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861025
Basic UDI-DI: B-06975278861025
Reference: XRDL041A120OS
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861018

TB Specific Cellular Immune Response (TB-IGRA) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861018
Basic UDI-DI: B-06975278861018
Reference: XRDL041A105OS
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278861001

Gastrin 17 (G-17) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278861001
Basic UDI-DI: B-06975278861001
Reference: XRDL040A120OS
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975278860998

Gastrin 17 (G-17) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278860998
Basic UDI-DI: B-06975278860998
Reference: XRDL040A105OS
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:04

Manufacturer products Authorised representative products Authorised representative actors View details

06975278860981

Serum Amyloid A (SAA) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSingle use

Manufacturer: Xenta Biomedical Science Co., Ltd.
Manufacturer SRN: CN-MF-000057746
UDI-DI: 06975278860981
Basic UDI-DI: B-06975278860981
Reference: XRDL039A120OS
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 30.09.2026 16:04

Manufacturer products Authorised representative products Authorised representative actors View details