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770 device results listed.

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MAGLUMI Anti-HAV (CLIA) Controls

Anti-HAV (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: 06947145546649
Basic UDI-DI: 694714551045J2
Reference: 1602011045MT
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 10:53

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 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

MAGLUMI EBV NA IgA (CLIA) Controls

EBV NA IgA (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: 06947145519766
Basic UDI-DI: 69471455451WC
Reference: 160201451MT
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

MAGLUMI Chlamydia pneumoniae IgM (CLIA) Controls

Chlamydia pneumoniae 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: 06947145518721
Basic UDI-DI: 69471455192WB
Reference: 160201192MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY 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 Chlamydia pneumoniae IgG (CLIA) Controls

Chlamydia pneumoniae IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518714
Basic UDI-DI: 69471455191W9
Reference: 160201191MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY 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 Mycoplasma pneumoniae IgM (CLIA) Controls

Mycoplasma pneumoniae 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: 06947145518707
Basic UDI-DI: 69471455190W7
Reference: 160201190MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY 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 Mycoplasma pneumoniae IgG (CLIA) Controls

Mycoplasma pneumoniae IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518691
Basic UDI-DI: 69471455189WN
Reference: 160201189MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY 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 HSV-2 IgM (CLIA) Controls

HSV-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: 06947145518660
Basic UDI-DI: 69471455161VY
Reference: 160201161MT
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 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HSV-1 IgM (CLIA) Controls

HSV-1 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: 06947145518653
Basic UDI-DI: 69471455160VW
Reference: 160201160MT
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 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI EBV EA IgA (CLIA) Controls

EBV EA IgA (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: 06947145540104
Basic UDI-DI: 694714551006HQ
Reference: 1602011006MT
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 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI EBV VCA IgA (CLIA) Controls

EBV VCA IgA (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: 06947145540067
Basic UDI-DI: 694714551005HN
Reference: 1602011005MT
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 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI EBV EA IgG (CLIA) Controls

EBV EA IgG (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: 06947145539900
Basic UDI-DI: 694714551001HE
Reference: 1602011001MT
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 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI H.pylori IgM (CLIA) Controls

H.pylori IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145523404
Basic UDI-DI: 694714551015HR
Reference: 1602011015MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

05902643958876

Respiratory Antigens Negative Control

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958876
Basic UDI-DI: 59026439BRTK868QZ
Reference: 1-868-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958869

Respiratory Antigens Negative Control

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958869
Basic UDI-DI: 59026439BRTK867QX
Reference: 1-867-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958852

Kontrola pozytywna Cryptosporidium

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958852
Basic UDI-DI: 59026439BRTK829QP
Reference: 1-829-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958845

Kontrola pozytywna H. pylori Ag

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958845
Basic UDI-DI: 59026439BRTK827QK
Reference: 1-827-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958838

Kontrola pozytywna C. difficile Tox. B

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958838
Basic UDI-DI: 59026439BRTK826QH
Reference: 1-826-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details