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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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467 device results listed.

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Biossays Cholinesterase (Butyrylthiocholine)

Cholinesterase (Butyrylthiocholine)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145561178
Basic UDI-DI: 69471455543WJ
Reference: 130502012A
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cholinesterase (Butyrylthiocholine)

Cholinesterase (Butyrylthiocholine)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145561130
Basic UDI-DI: 69471455543WJ
Reference: 130502012S
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

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: 06947145560874
Basic UDI-DI: 69471455596X7
Reference: 130552010S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Apolipoprotein E (Immunoturbidimetric)

Apolipoprotein E (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145560591
Basic UDI-DI: 69471455574WV
Reference: 130551005S
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Wash Concentrate

Wash Concentrate

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145557041
Basic UDI-DI: 69471455303VU
Reference: 130299035M
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

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: 06947145552657
Basic UDI-DI: 69471455592WX
Reference: 130554003S
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

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: 06947145552572
Basic UDI-DI: 69471455591WV
Reference: 130554002S
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 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Total Bile Acids (Enzymatic Cycling)

Total Bile Acids (Enzymatic Cycling)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145551452
Basic UDI-DI: 69471455577X3
Reference: 130552001S
EMDN: W01010202
EMDN description: BILE ACIDS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Lipoprotein (a) (Latex Immunoturbidimetric)

Lipoprotein (a) (Latex Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145551292
Basic UDI-DI: 69471455575WX
Reference: 130551006S
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays C-Reactive Protein (Latex Immunoturbidimetric)

C-Reactive Protein (Latex Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145549510
Basic UDI-DI: 69471455618WQ
Reference: 130558008A
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays C-Reactive Protein (Latex Immunoturbidimetric)

C-Reactive Protein (Latex Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145549480
Basic UDI-DI: 69471455618WQ
Reference: 130558008S
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays β-Hydroxybutyrate (β-Hydroxybutyrate Dehydrogenase)

β-Hydroxybutyrate (β-Hydroxybutyrate Dehydrogenase)

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548223
Basic UDI-DI: 69471455561WL
Reference: 130505006S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays β-Hydroxybutyrate (β-Hydroxybutyrate Dehydrogenase)

β-Hydroxybutyrate (β-Hydroxybutyrate Dehydrogenase)

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548209
Basic UDI-DI: 69471455561WL
Reference: 130505006A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cystatin C (Latex)

Cystatin C (Latex)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548148
Basic UDI-DI: 69471455558WX
Reference: 130503006A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Hemoglobin A1c (Latex)

Hemoglobin A1c (Latex)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548124
Basic UDI-DI: 69471455551WH
Reference: 130505002A
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

U turn - Outer

IOM-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547042
Basic UDI-DI: 69471455SATLARST83K
Reference: 010103002901
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

L turn

IOM-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547035
Basic UDI-DI: 69471455SATLARST83K
Reference: 010103002801
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

T turn

IOM-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547028
Basic UDI-DI: 69471455SATLARST83K
Reference: 010103002701
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Input/Output Module

IOM-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145546946
Basic UDI-DI: 69471455SATLARST83K
Reference: 010103002101
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI X6

Fully-auto chemiluminescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145528782
Basic UDI-DI: 69471455X6GB
Reference: 010101006601
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details