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VIRAPID® ADENOVIRUS Ag FIA

VRF001

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290593
Basic UDI-DI: 843661029VRF00101QR
Reference: VRF001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

Simple RSV-RespirAdeno

9.110.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003269
Basic UDI-DI: 84295779110XH
Reference: 9.110.020.47.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple RespirAdeno

9.091.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003238
Basic UDI-DI: 84295779091Y6
Reference: 9.091.020.46.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple Flu A+B

9.080.XX.YYY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003214
Basic UDI-DI: 84295779080XZ
Reference: 9.080.020.46.000
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple RSV

9.064.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003191
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.46.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple Rota-Adeno-Noro

9.050.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003047
Basic UDI-DI: 84295779050XQ
Reference: 9.050.020.20.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

SIMPLE ROTA-ADENO / STICK ROTA-ADENO

9.024.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577000862
Basic UDI-DI: 84295779024XP
Reference: 9.024.020.21.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

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

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643959248
Basic UDI-DI: 59026439BRT306JG
Reference: 1-306-K010
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643958630

Dengue Ab/Ag kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958630
Basic UDI-DI: 59026439BRT355JV
Reference: 1-355-K020
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958623

Dengue NS1 kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958623
Basic UDI-DI: 59026439BRT354JT
Reference: 1-354-K020
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958616

Dengue - kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958616
Basic UDI-DI: 59026439BRT353JR
Reference: 1-353-K020
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958579

Mononucleosis 25 tests

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958579
Basic UDI-DI: 59026439BRT345JS
Reference: 1-345-K025
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958531

Adeno-resp. - kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958531
Basic UDI-DI: 59026439BRT341JJ
Reference: 1-341-K020
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details