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377 device results listed.

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MAGLUMI Fully-auto chemiluminescence immunoassay analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588502
Basic UDI-DI: 69471455X103G
Reference: 010101010001
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.09.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Fully-auto chemiluminescence immunoassay analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588496
Basic UDI-DI: 69471455X103G
Reference: 010101004401
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.09.2026 03:41

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Module I

SPU-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145598822
Basic UDI-DI: 69471455mT89N
Reference: 073801000801
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.08.2026 02:08

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Module II

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145598839
Basic UDI-DI: 69471455mT89N
Reference: 073801000901
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Cold Storage Unit (5550)

SPU-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145597368
Basic UDI-DI: 69471455mT89N
Reference: 010103008501
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

SATLAR Sample tube cap

Sample tube cap

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145597931
Basic UDI-DI: 694714553310JC
Reference: 021711000501
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing Unit

SPU-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145597320
Basic UDI-DI: 69471455mT89N
Reference: 010103008001
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi PT (Clotting Assay)

PT (Clotting Assay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145553593
Basic UDI-DI: B-06947145553593
Reference: 133101001NSNM1
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Rheumatism & Inflammation Multi-Calibrator

Rheumatism & Inflammation Multi-Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145593728
Basic UDI-DI: 69471455C12Y8
Reference: 1601020047
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Protein Multiconstituent Calibrators

Protein Multiconstituent Calibrators

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

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145589226
Basic UDI-DI: 69471455C07YF
Reference: 1601020046
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Immunoassay Multiconstituent Calibrators

Immunoassay Multiconstituent Calibrators

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145589202
Basic UDI-DI: 69471455C06YD
Reference: 1601020045
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Myeloperoxidase (Latex Immunoturbidimetric)

Myeloperoxidase (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145589134
Basic UDI-DI: 69471455643WP
Reference: 130504013S
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Serum Amyloid A (Latex Immunoturbidimetric)

Serum Amyloid 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: 06947145588953
Basic UDI-DI: 69471455642WM
Reference: 130513001S
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α2-Macroglobulin (Immunoturbidimetric)

α2-Macroglobulin (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: 06947145588755
Basic UDI-DI: 69471455641WK
Reference: 130503013S
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ferritin (Latex Immunoturbidimetric)

Ferritin (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: 06947145570910
Basic UDI-DI: 69471455605WF
Reference: 130510001A
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Angiotensin Converting Enzyme (FAPGG Substrate)

Angiotensin Converting Enzyme (FAPGG Substrate)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145569860
Basic UDI-DI: 69471455601W7
Reference: 130504008A
EMDN: W01010109
EMDN description: ANGIOTENSIN CONVERTING ENZYME (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Angiotensin I (CLIA)

Angiotensin I (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580629
Basic UDI-DI: 694714551037J3
Reference: 1306563005M
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls

Dengue virus NS1 Antigen (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145565329
Basic UDI-DI: 69471455401VV
Reference: 160201401MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Pancreatic Amylase (Immunoinhibition-EPS)

Pancreatic Amylase (Immunoinhibition-EPS)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145558161
Basic UDI-DI: 69471455639WY
Reference: 130506003S
EMDN: W01010108
EMDN description: AMYLASE ISOENZYMES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Immunoglobulin G (Latex Immunoturbidimetric)

Immunoglobulin G (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: 06947145557928
Basic UDI-DI: 69471455638WW
Reference: 130503012S
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details