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23.09.2026 04:15

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Active filter:Manufacturer SRN:CN-MF-000030226

22 device results listed.

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H&W Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)

123145-01-102 123145-02-102 123145-05-102 123145-20-102

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

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892393
Basic UDI-DI: 697416789123145ZT
Reference: HW-8combo-2026-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 22.09.2026 17:20

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

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

IVD Class CIVDR 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: 697416789123143ZP
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: 22.09.2026 00:59

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

OXA-23 carbapenemase Test Kit (LFIA)

124113-20-161

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-124113-20-161D8
Basic UDI-DI: B-124113-20-161D8
Reference: 124113-20-161
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.08.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

OXA-23 carbapenemase Test Kit (LFIA)

124113-01-161

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-124113-01-161CR
Basic UDI-DI: B-124113-01-161CR
Reference: 124113-01-161
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.08.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

H&W SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

123143-01-102 123143-02-102 123143-05-102 123143-20-102

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: 06974167891631
Basic UDI-DI: 697416789100NQ
Reference: HW-5combo-2025-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 24.07.2026 09:59

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

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

211045-20-061

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-211045-20-061CQ
Basic UDI-DI: B-211045-20-061CQ
Reference: 211045-20-061
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Poland
Authorised representative: R Sight B.V.
Last updated: 17.07.2026 01:49

Manufacturer products Authorised representative products Authorised representative actors View details

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

211045-01-061

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-211045-01-061C9
Basic UDI-DI: B-211045-01-061C9
Reference: 211045-01-061
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Poland
Authorised representative: R Sight B.V.
Last updated: 17.07.2026 01:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974167892263

123145-01-102 123145-02-102 123145-05-102 123145-20-102

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

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892263
Basic UDI-DI: 697416789123145ZT
Reference: 123145-01-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 16.07.2026 11:09

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

Heltiso TEST COMBO ANTYGENOWY SARS-COV-2/ GRYPA A/ GRYPA B + ADV/ RSV

123143-01-102 123143-02-102 123143-05-102 123143-20-102

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: 06974167892188
Basic UDI-DI: 697416789100NQ
Reference: 123143-01-102-PL03
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 16.07.2026 11:09

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

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

211045-20-01

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891860
Basic UDI-DI: B-06974167891860
Reference: 211045-20-01
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Austria
Authorised representative: R Sight B.V.
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891754
Basic UDI-DI: B-06974167891754
Reference: 123015-01-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891747
Basic UDI-DI: B-06974167891747
Reference: 123015-20-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 AntigenTest kit (LFIA)

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167890054
Basic UDI-DI: B-06974167890054
Reference: 1031-14-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: R Sight B.V.
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

Group A streptococcus Rapid test Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-012124L3
Basic UDI-DI: B-012124L3
Reference: 012124-20-111
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Finland
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.07.2026 16:09

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

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

06974167892171

123145-01-102 123145-02-102 123145-05-102 123145-20-102

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

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892171
Basic UDI-DI: 697416789123145ZT
Reference: 123145-20-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

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

06974167892164

123145-01-102 123145-02-102 123145-05-102 123145-20-102

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

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892164
Basic UDI-DI: 697416789123145ZT
Reference: 123145-05-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

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

06974167892157

123145-01-102 123145-02-102 123145-05-102 123145-20-102

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

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892157
Basic UDI-DI: 697416789123145ZT
Reference: 123145-02-102
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 30.06.2026 12:10

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