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COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold)Saliva

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062777816
Basic UDI-DI: B-06952062777816
Reference: SL030101SST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest Norovirus

CerTest Norovirus

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440206002
Basic UDI-DI: 84354402IDXGASTROB_NN7R
Reference: NN820001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

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CerTest Rotavirus+Adenovirus+Astrovirus

CerTest Rotavirus+Adenovirus+Astrovirus

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205982
Basic UDI-DI: 84354402IDXGASTROB_RT8H
Reference: RT872001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

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CerTest Rota+Adeno+Astro+Noro

CerTest Rota+Adeno+Astro+Noro

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200277
Basic UDI-DI: 84354402IDXGASTROB_RG7P
Reference: RG862001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

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CerTest ROTA+ADENO+NORO

CerTest ROTA+ADENO+NORO

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200260
Basic UDI-DI: 84354402IDXGASTROB_RA7B
Reference: RA872001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

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CerTest Rotavirus+Norovirus GI/GII

CerTest Rotavirus+Norovirus GI/GII

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200253
Basic UDI-DI: 84354402IDXGASTROB_RN85
Reference: RN882001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

CerTest Norovirus GI+GII

CerTest Norovirus GI+GII

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200246
Basic UDI-DI: 84354402IDXGASTROB_NV89
Reference: NV882001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:18

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CerTest Astrovirus

CerTest Astrovirus

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200208
Basic UDI-DI: 84354402IDXGASTROB_AT6W
Reference: AT820001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:18

Manufacturer products View details

CerTest Rotavirus+Adenovirus

CerTest Rotavirus+Adenovirus

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200185
Basic UDI-DI: 84354402IDXGASTROB_XR8X
Reference: XR882001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:18

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CerTest Adenovirus

CerTest Adenovirus

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200161
Basic UDI-DI: 84354402IDXGASTROB_AD5W
Reference: AD820001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:18

Manufacturer products View details

CerTest Rotavirus

CerTest Rotavirus

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200147
Basic UDI-DI: 84354402IDXGASTROB_R4T
Reference: R820001V
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:18

Manufacturer products View details

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

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