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370 device results listed.

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Hemolumi Automated coagulation analyzer

Automated Coagulation Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145541835
Basic UDI-DI: 69471455H6ET
Reference: 010111000101
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-GBM IgG (CLIA) Controls

Anti-GBM IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145540500
Basic UDI-DI: 69471455268WK
Reference: 160201268MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-PR3 IgG (CLIA) Controls

Anti-PR3 IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145540463
Basic UDI-DI: 69471455185WE
Reference: 160201185MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-Cardiolipin IgM (CLIA) Controls

Anti-Cardiolipin IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145540364
Basic UDI-DI: 69471455437WJ
Reference: 160201437MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-Cardiolipin IgG (CLIA) Controls

Anti-Cardiolipin IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145540340
Basic UDI-DI: 69471455436WG
Reference: 160201436MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-β2-Glycoprotein 1 IgM (CLIA) Controls

Anti-β2-Glycoprotein 1 IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145531812
Basic UDI-DI: 69471455441W9
Reference: 160201441MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-β2-Glycoprotein 1 IgG (CLIA) Controls

Anti-β2-Glycoprotein 1 IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145531775
Basic UDI-DI: 69471455440W7
Reference: 160201440MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI hs-CRP (CLIA) Controls

hs-CRP (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: 06947145529482
Basic UDI-DI: 69471455494WW
Reference: 160201494MT
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Cholylglycine (CLIA) Controls

Cholylglycine (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529369
Basic UDI-DI: 69471455466WR
Reference: 160201466MT
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI PIIIP N-P (CLIA) Controls

PIIIP N-P (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529321
Basic UDI-DI: 69471455465WP
Reference: 160201465MT
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Hyaluronic Acid (CLIA) Controls

Hyaluronic Acid (CLIA) Controls

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529284
Basic UDI-DI: 69471455464WM
Reference: 160201464MT
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI PAP (CLIA) Controls

PAP (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: 06947145529161
Basic UDI-DI: 69471455456WN
Reference: 160201456MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HEV IgM (CLIA) Controls

HEV IgM (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: 06947145523152
Basic UDI-DI: 69471455215VW
Reference: 160201215MT
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HEV IgG (CLIA) Controls

HEV IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145523114
Basic UDI-DI: 69471455214VU
Reference: 160201214MT
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Unconjugated Estriol (CLIA) Controls

Unconjugated Estriol (CLIA) Controls

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529123
Basic UDI-DI: 69471455260W3
Reference: 160201260MT
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HSV-1/2 IgM (CLIA) Controls

HSV-1/2 IgM (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: 06947145526726
Basic UDI-DI: 69471455484WT
Reference: 160201484MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi Sample Diluent

Sample Diluent

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145522063
Basic UDI-DI: 694714557202K4
Reference: 130104002NSM
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi Sample Diluent

Sample Diluent

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145522056
Basic UDI-DI: 694714557201K2
Reference: 130104001NSM
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI β2-Microglobulin (CLIA) Controls

β2-Microglobulin (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: 06947145520984
Basic UDI-DI: 69471455489X5
Reference: 160201489MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Osteocalcin (CLIA) Controls

Osteocalcin (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145520861
Basic UDI-DI: 69471455475WS
Reference: 160201475MT
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details