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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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

GCFCRA-T525a-DRH1，GCFCRA-T525a-DRH5，GCFCRA-T525a-DRH7，GCFCRA-T525a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002806
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:48

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002813
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002820
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002837
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

Aria RSV Ag Rapid Test

R0186C

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461327
Basic UDI-DI: 081011446R0186CEN
Reference: R0186C-20T-AR
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

Aria Influenza A/B Ag Rapid Test

R0187C

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461310
Basic UDI-DI: 081011446R0187CER
Reference: R0187C-20T-AR
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Norovirus GI/GII Test

Norovirus GI/GII Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-920002T7
Basic UDI-DI: B-nvm-920002T7
Reference: 920002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:29

Manufacturer products View details

NADAL® Dengue NS1 Ag+IgG/IgM Test

Dengue NS1 Ag+IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-532919N-105A
Basic UDI-DI: B-nvm-532919N-105A
Reference: 532919N-10
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

NADAL® RSV Test

RSV Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-491905N-206E
Basic UDI-DI: B-nvm-491905N-206E
Reference: 491905N-20
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

NADAL® Mononucleosis Test

Mononucleosis Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-252003N-20UR
Basic UDI-DI: B-nvm-252003N-20UR
Reference: 252003N-20
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

NADAL® Influenza A/B Test

Influenza A/B Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-242915N-10ZT
Basic UDI-DI: B-nvm-242915N-10ZT
Reference: 242915N-10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Influenza A/B Test

Influenza A/B Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-242015N-10V2
Basic UDI-DI: B-nvm-242015N-10V2
Reference: 242015N-10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

D-ZIKANS1-W23YD

Zika NS1 Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-ZIKANS1-W23YD
Basic UDI-DI: B-ZIKANS1-W23YD
Reference: ZIKA-NS1-W23
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/lgM Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ZIKA-D22aHA
Basic UDI-DI: B-ZIKA-D22aHA
Reference: ZIKA-D22a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MPXV-C91-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MPXV-C91-25MN
Basic UDI-DI: B-WI-MPXV-C91-25MN
Reference: WI-MPXV-C91-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MPXV-C42-25

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MPXV-C42-25L6
Basic UDI-DI: B-WI-MPXV-C42-25L6
Reference: WI-MPXV-C42-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C86A-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C86A-25CQ
Basic UDI-DI: B-WI-MICR-C86A-25CQ
Reference: WI-MICR-C86A-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C85A-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C85A-25CD
Basic UDI-DI: B-WI-MICR-C85A-25CD
Reference: WI-MICR-C85A-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C83A-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C83A-25BP
Basic UDI-DI: B-WI-MICR-C83A-25BP
Reference: WI-MICR-C83A-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details