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467 device results listed.

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Biossays Non-Esterified Fatty Acids (ACS-ACOD)

Non-Esterified Fatty Acids (ACS-ACOD)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584276
Basic UDI-DI: 69471455609WP
Reference: 130551501A
EMDN: W01010222
EMDN description: NON ESTERIFIED FATTY ACIDS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Prealbumin (Immunoturbidimetric)

Prealbumin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584245
Basic UDI-DI: 69471455607WK
Reference: 130552011S
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Prealbumin (Immunoturbidimetric)

Prealbumin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584191
Basic UDI-DI: 69471455607WK
Reference: 130552011A
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ammonia (Glutamate dehydrogenase)

Ammonia (Glutamate dehydrogenase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584177
Basic UDI-DI: 69471455596X7
Reference: 130552010A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α-Amylase (EPS Substrate)

α-Amylase (EPS Substrate)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584160
Basic UDI-DI: 69471455594X3
Reference: 130556001A
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Lactate Dehydrogenase (Lactic Acid Substrate)

Lactate Dehydrogenase (Lactic Acid Substrate)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584153
Basic UDI-DI: 69471455593WZ
Reference: 130554004A
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α-Hydroxybutyrate Dehydrogenase (α-Ketobutyrate Substrate)

α-Hydroxybutyrate Dehydrogenase (α-Ketobutyrate Substrate)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584146
Basic UDI-DI: 69471455592WX
Reference: 130554003A
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Creatine Kinase-MB (Immunosuppressive)

Creatine Kinase-MB (Immunosuppressive)

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584139
Basic UDI-DI: 69471455591WV
Reference: 130554002A
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Creatine Kinase (Phosphate Creatine Substrate)

Creatine Kinase (Phosphate Creatine Substrate)

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584122
Basic UDI-DI: 69471455590WT
Reference: 130554001A
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Urea (Urease-Glutamate Dehydrogenase)

Urea (Urease-Glutamate Dehydrogenase)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584115
Basic UDI-DI: 69471455589XA
Reference: 130553003A
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Albumin (Bromocresol Green)

Albumin (Bromocresol Green)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584108
Basic UDI-DI: 69471455588X8
Reference: 130552009A
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Total Protein (Biuret)

Total Protein (Biuret)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584092
Basic UDI-DI: 69471455587X6
Reference: 130552008A
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Direct Bilirubin (Vanadate Oxidation)

Direct Bilirubin (Vanadate Oxidation)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584085
Basic UDI-DI: 69471455586X4
Reference: 130552007A
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Total Bilirubin (Vanadate Oxidation)

Total Bilirubin (Vanadate Oxidation)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584078
Basic UDI-DI: 69471455585X2
Reference: 130552006A
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays γ-Glutamyl Transferase (GCANA Substrate)

γ-Glutamyl Transferase (GCANA Substrate)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584061
Basic UDI-DI: 69471455584WY
Reference: 130552005A
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Alkaline Phosphatase (NPP Substrate-AMP Buffer)

Alkaline Phosphatase (NPP Substrate-AMP Buffer)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584054
Basic UDI-DI: 69471455583WW
Reference: 130552004A
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Uric Acid (Uricase)

Uric Acid (Uricase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584030
Basic UDI-DI: 69471455581WS
Reference: 130553002A
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Glucose (Hexokinase)

Glucose (Hexokinase)

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584047
Basic UDI-DI: 69471455582WU
Reference: 130555001A
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Creatinine (Sarcosine Oxidase)

Creatinine (Sarcosine Oxidase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584023
Basic UDI-DI: 69471455580WQ
Reference: 130553001A
EMDN: W01010207
EMDN description: CREATININE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Aspartate Aminotransferase (Aspartic Acid Substrate)

Aspartate Aminotransferase (Aspartic Acid Substrate)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145584016
Basic UDI-DI: 69471455579X7
Reference: 130552003A
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details