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370 device results listed.

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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

Biossays Anti-Streptolysin O (Latex)

Anti-Streptolysin O (Latex)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145519285
Basic UDI-DI: 69471455552WK
Reference: 130508006A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Anti-Streptolysin O (Latex)

Anti-Streptolysin O (Latex)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145519247
Basic UDI-DI: 69471455552WK
Reference: 130508006S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Retinol Binding Protein (Latex)

Retinol Binding Protein (Latex)

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: 06947145519148
Basic UDI-DI: 69471455550WF
Reference: 130503008A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Retinol Binding Protein (Latex)

Retinol Binding Protein (Latex)

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: 06947145519100
Basic UDI-DI: 69471455550WF
Reference: 130503008S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays N-Acetyl-β-D-Glucosaminidase (MPT)

N-Acetyl-β-D-Glucosaminidase (MPT)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518097
Basic UDI-DI: 69471455563WQ
Reference: 130503009A
EMDN: W01010126
EMDN description: N-ACETYL-B, D-GLUCOSAMINIDASE
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

Biossays N-Acetyl-β-D-Glucosaminidase (MPT)

N-Acetyl-β-D-Glucosaminidase (MPT)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518059
Basic UDI-DI: 69471455563WQ
Reference: 130503009S
EMDN: W01010126
EMDN description: N-ACETYL-B, D-GLUCOSAMINIDASE
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

Biossays 5’-Nucleotidase (Peroxidase)

5’-Nucleotidase (Peroxidase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516369
Basic UDI-DI: 69471455564WS
Reference: 130502015A
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
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

Biossays 5’-Nucleotidase (Peroxidase)

5’-Nucleotidase (Peroxidase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516321
Basic UDI-DI: 69471455564WS
Reference: 130502015S
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
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

Biossays Glycated Serum Protein (NBT)

Glycated Serum Protein (NBT)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516307
Basic UDI-DI: 69471455560WJ
Reference: 130505005A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Glycated Serum Protein (NBT)

Glycated Serum Protein (NBT)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516260
Basic UDI-DI: 69471455560WJ
Reference: 130505005S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Glycated Albumin (Peroxidase)

Glycated Albumin (Peroxidase)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516246
Basic UDI-DI: 69471455559WZ
Reference: 130505004A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Glycated Albumin (Peroxidase)

Glycated Albumin (Peroxidase)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516208
Basic UDI-DI: 69471455559WZ
Reference: 130505004S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Haptoglobin (Immunoturbidimetric)

Haptoglobin (Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516185
Basic UDI-DI: 69471455555WR
Reference: 130502014A
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
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

Biossays Haptoglobin (Immunoturbidimetric)

Haptoglobin (Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145516147
Basic UDI-DI: 69471455555WR
Reference: 130502014S
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
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 Sample Extraction Solution

Sample Extraction Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145514945
Basic UDI-DI: 69471455323W2
Reference: 130299031M
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 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Rheumatoid Factor (Latex)

Rheumatoid Factor (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: 06947145514037
Basic UDI-DI: 69471455553WM
Reference: 130508007A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Preaccu

Preaccu for Prenatal Screening

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145513597
Basic UDI-DI: 69471455Preaccu6W
Reference: 22010315
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
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