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FilmArray® Meningitis/Encephalitis (ME) Panel

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020123
Basic UDI-DI: 357302BUDI000004SJ
Reference: RFIT-ASY-0118
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® Gastrointestinal (GI) Panel

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020116
Basic UDI-DI: 357302BUDI000005SL
Reference: RFIT-ASY-0104
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Kit WDT-96

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagent

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318132873
Basic UDI-DI: 697431813E-KitH4
Reference: 940-002012-00
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Kit WDT-864

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagent

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318132880
Basic UDI-DI: 697431813E-KitH4
Reference: 940-002011-00
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

CMV ELITe MGB® Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483937
Basic UDI-DI: 803389148CMV19C8
Reference: RTK015PLD
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 29.07.2026 11:50

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Tetanus IgG Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-TET-402Y3
Basic UDI-DI: B-FI-TET-402Y3
Reference: FI-TET-402
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI - 05

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074569438
Basic UDI-DI: B-18906074569438
Reference: HV4ELI - 05
EMDN: W0105030302
EMDN description: HIV P24 ANTIBODY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI - 09

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001665
Basic UDI-DI: B-08905459001665
Reference: HV4ELI - 09
EMDN: W0105030302
EMDN description: HIV P24 ANTIBODY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI – 08

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001269
Basic UDI-DI: B-08905459001269
Reference: HV4ELI – 08
EMDN: W0105030301
EMDN description: HIV P24 ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HPBELI-06

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001221
Basic UDI-DI: B-08905459001221
Reference: HPBELI-06
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673999520
Basic UDI-DI: B-08431673999520
Reference: 1205006-P
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

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BACTERIAL ANTIGENS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673951610
Basic UDI-DI: B-08431673951610
Reference: 1205008-F
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673950507
Basic UDI-DI: B-08431673950507
Reference: 1205008-D
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673950484
Basic UDI-DI: B-08431673950484
Reference: 1205008-E
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939434
Basic UDI-DI: B-08431673939434
Reference: 1205006-Q
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939427
Basic UDI-DI: B-08431673939427
Reference: 1205006-I
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939342
Basic UDI-DI: B-08431673939342
Reference: 1205006-X
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939298
Basic UDI-DI: B-08431673939298
Reference: 1205006-M
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:08

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939311
Basic UDI-DI: B-08431673939311
Reference: 1205006-O
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

BACTERIAL ANTIGENS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939304
Basic UDI-DI: B-08431673939304
Reference: 1205006-N
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details