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INFLUENZATOP BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678588902
Basic UDI-DI: B-03532678588902
Reference: SW40002
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B+COVID-19/RSV Combo Ag Test

Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: CorDx, Inc.
Manufacturer SRN: US-MF-000029255
UDI-DI: 00850067912569
Basic UDI-DI: B-00850067912569
Reference: HWP292-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 05.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Dengue NS1 Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561604
Basic UDI-DI: B-00628347561604
Reference: A03-22-222
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242DEN003-256L

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242DEN003-256L
Basic UDI-DI: B-000041242DEN003-256L
Reference: DEN003-25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242DEN003-056E

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242DEN003-056E
Basic UDI-DI: B-000041242DEN003-056E
Reference: DEN003-05
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242DEN003-0166

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242DEN003-0166
Basic UDI-DI: B-000041242DEN003-0166
Reference: DEN003-01
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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)

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

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® INFLUENZA A/INFLUENZA B Ag FIA

VRF004

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290791
Basic UDI-DI: 843661029VRF00401R8
Reference: VRF004
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

VIRAPID® RESPIRATORY SYNCYTIAL VIRUS Ag FIA

VRF003

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290784
Basic UDI-DI: 843661029VRF00301R3
Reference: VRF003
EMDN: W0105099002
EMDN description: RSV - RT & POC
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