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EUDAMED Device Search

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

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Last updated

03.08.2026 02:01

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Device

2993593

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Active filter:EMDN:W01050808

704 device results listed.

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CONTROL POSITIVO EN SECO ROTA-ADENO-NORO || DRY POSITIVE CONTROL ROTA-ADENO-NORO

9.050.XXX.12.ZZZ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
OPERON, S.A.
Manufacturer SRN
ES-MF-000004790
UDI-DI
08429577003481
Basic UDI-DI
8429577905012CH
Reference
9.050.011.12.000
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Spain
Authorised representative
-
Last updated
03.07.2026 13:17
Manufacturer productsView details
REDx Mycoplasma genitalium Positive Control

RED-63-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesSingle useSterile
Manufacturer
Microbix Biosystems Inc.
Manufacturer SRN
CA-MF-000028149
UDI-DI
07540224000149
Basic UDI-DI
754022447323AJ
Reference
RED-63-01
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
03.07.2026 05:26
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
REDxFLOQ Respiratory Swab Negative Control

RED-S-99-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesSingle use
Manufacturer
Microbix Biosystems Inc.
Manufacturer SRN
CA-MF-000028149
UDI-DI
07540224000309
Basic UDI-DI
754022464922BF
Reference
RED-S-99-01
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
03.07.2026 05:26
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
REDx SARS-CoV-2 Positive Control

RED-19-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesSingle use
Manufacturer
Microbix Biosystems Inc.
Manufacturer SRN
CA-MF-000028149
UDI-DI
07540224000217
Basic UDI-DI
754022464748BP
Reference
RED-19-01
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
03.07.2026 05:26
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
REDx HPV 16 Positive Control

RED-62-16

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesSingle use
Manufacturer
Microbix Biosystems Inc.
Manufacturer SRN
CA-MF-000028149
UDI-DI
07540224000019
Basic UDI-DI
754022452766AY
Reference
RED-62-16
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
03.07.2026 05:26
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
GeneProof Universal Internal Control

-

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
GeneProof a.s.
Manufacturer SRN
CZ-MF-000002370
UDI-DI
08595696305086
Basic UDI-DI
859569630004Q9
Reference
UNIC/GP/010
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
-
Authorised representative
-
Last updated
02.07.2026 22:38
Manufacturer productsView details
06973315734875

Quality Control Kit for Logilet Respiratory Pathogen Panel

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000031032
UDI-DI
06973315734875
Basic UDI-DI
6973315734875B3
Reference
QC1011
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 14:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls

Anti-Dengue 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
06947145565343
Basic UDI-DI
69471455403VZ
Reference
160201403MT
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 productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls

Anti-Dengue Virus 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
06947145565336
Basic UDI-DI
69471455402VX
Reference
160201402MT
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 productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI CMV IgG (CLIA) Controls

CMV 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
06947145561765
Basic UDI-DI
69471455477WW
Reference
160201477MT
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 productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Toxo IgG (CLIA) Controls

Toxo 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
06947145561727
Basic UDI-DI
69471455476WU
Reference
160201476MT
EMDN
W0105080805
EMDN description
PARASITOLOGY CONTROLS - INF.IMM.
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 10:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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 productsAuthorised representative productsAuthorised representative actorsView details
MAGLUMI Legionella pneumophila IgM (CLIA) Controls

Legionella pneumophila 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
06947145547547
Basic UDI-DI
69471455276WJ
Reference
160201276MT
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 10:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details