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monogen kit 50 tests

Monogen

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950001676
Basic UDI-DI: 84269500016764Y
Reference: 3000-1001
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:02

Manufacturer products View details

GenSure Flu A+B Ag Rapid Test

Flu A+B Ag Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230302
Basic UDI-DI: 697683823P201800F4
Reference: P2018C01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Cyprus
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

LYHER

IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-40

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613991
Basic UDI-DI: 697241261IDE-A402EJ
Reference: IDE-A402-25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IAD-502-01; IAD-502-05; IAD-502-20; IAD-502-25; IAD-502-40

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612376
Basic UDI-DI: 697241261IAD-5026X
Reference: IAD-502-05
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IHMP-502-01;IHMP-502-05; IHMP-502-20; IHMP-502-25; IHMP-502-40

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611737
Basic UDI-DI: 697241261IHMP-502TL
Reference: IHMP-502-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

ReaScan TBE IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: 06430074452469
Basic UDI-DI: 643007445114106A7
Reference: 114106
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:59

Manufacturer products View details

ReaScan+ PUUMALA IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: 06430074452452
Basic UDI-DI: 643007445115105AC
Reference: 115105
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:59

Manufacturer products View details

05902643959248

Norovirus/ Rotavirus/ Adenovirus Combo 10 tests / INRA-635