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EUDAMED Device Search

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

Last updated

01.08.2026 16:25

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160 device results listed.

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MAGLUMI Respiratory Syncytial Virus IgM (CLIA) Controls

Respiratory Syncytial Virus 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: 06947145547622
Basic UDI-DI: 69471455277WL
Reference: 160201277MT
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 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Influenza B Virus IgM (CLIA) Controls

Influenza B Virus 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: 06947145547394
Basic UDI-DI: 69471455274WE
Reference: 160201274MT
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 10:53

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 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 Influenza B Virus IgM (CLIA)

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547400
Basic UDI-DI: 69471455274WE
Reference: 130619024M
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Influenza B Virus IgM (CLIA)

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547424
Basic UDI-DI: 69471455274WE
Reference: 130219024M
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Respiratory Syncytial Virus IgM (CLIA)

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547646
Basic UDI-DI: 69471455277WL
Reference: 130219019M
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Respiratory Syncytial Virus IgM (CLIA)

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547677
Basic UDI-DI: 69471455277WL
Reference: 130619019M
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Rub G QC

-

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600536
Basic UDI-DI: 0405686902037V8
Reference: 10995671
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Paediatric G-2, 1x pos, 1mL

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956395
Basic UDI-DI: 0816784020098YL
Reference: SR15025
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Paediatric G-2, 2x pos, 2,5mL

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956814
Basic UDI-DI: 0816784020098YL
Reference: SR15027
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Mumps M, 2x pos, 2.5mL

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957040
Basic UDI-DI: 0816784020091Y6
Reference: SR15067
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Mumps M, 2x pos, 1mL

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957057
Basic UDI-DI: 0816784020091Y6
Reference: SR15068
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Chagas-1, 2x pos, 2.5mL

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957095
Basic UDI-DI: 0816784020106XS
Reference: SR16027
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Chagas-2, 2x pos, 2.5mL

-

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957118
Basic UDI-DI: 0816784020107XU
Reference: SR16037
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details