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TEST COMBO 8w1 SARS-CoV-2/ Grypa A/ Grypa B/ RSV/ ADV/ PIV/ HRV/ MPV Szybki test do samokontroli metodą (LFIA)

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IVD Class CIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892270
Basic UDI-DI: 697416789123145ZT
Reference: 123145-01-102-PL
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 03.07.2026 22:47

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

Mila8 TEST Combo

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IVD Class CIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892478
Basic UDI-DI: 697416789123145ZT
Reference: 123145-01-102-PL01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 03.07.2026 22:47

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

SEMA ROTECT TEST SARS-CoV-2/Grypa A/Grypa B +ADV/RSV Antygen Combo szybki test (LFIA)

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IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892492
Basic UDI-DI: 697416789100NQ
Reference: 123143-01-102-PL02
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 03.07.2026 22:47

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

Mila5 Test Combo

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IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892461
Basic UDI-DI: 697416789100NQ
Reference: 123143-01-102-PL04
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 03.07.2026 22:46

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

VIRAPID® ROTA/ADENO/NORO GI/NORO GII Ag

VRC006

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290890
Basic UDI-DI: 843661029VRC00601QB
Reference: VRC006
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

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 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

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

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

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

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

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

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

RSV+Adeno-resp.+Influenza A+B kas. 20 t.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958555
Basic UDI-DI: 59026439BRT343JN
Reference: 1-343-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

Norovirus kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958395
Basic UDI-DI: 59026439BRT323JG
Reference: 1-323-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

Rota / Adeno kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958128
Basic UDI-DI: 59026439BRT305JE
Reference: 1-305-K020
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

ICA2114-7

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564472
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

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