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ADENOVIRUS R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387723
Basic UDI-DI: 357302BUDI000440TA
Reference: 69-010B
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

ENTEROVIRUS R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387709
Basic UDI-DI: 357302BUDI000551TL
Reference: 69-005B
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

EBV R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387648
Basic UDI-DI: 357302BUDI000198TS
Reference: 69-002B
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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Parvovirus B19 R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026383190
Basic UDI-DI: 357302BUDI000442TE
Reference: 69-019B
EMDN: W0105040509
EMDN description: PARVOVIRUS B 19 - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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VIDAS® EBV VCA/EA IgG

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064617
Basic UDI-DI: 357302BUDI000080T2
Reference: 30236
EMDN: W010504040105
EMDN description: EBV VCA IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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VIDAS® EBV EBNA IgG

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064600
Basic UDI-DI: 357302BUDI000079TH
Reference: 30235
EMDN: W010504040106
EMDN description: EBV EBNA IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® EBV VCA IgM

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064624
Basic UDI-DI: 357302BUDI000081T4
Reference: 30237
EMDN: W010504040104
EMDN description: EBV VCA IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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VIDAS® RUB IgG II

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064556
Basic UDI-DI: 357302BUDI000077TD
Reference: 30221
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® CMV IgG

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064389
Basic UDI-DI: 357302BUDI000590TW
Reference: 30204
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

HSV 2 IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISGMB-402DD
Basic UDI-DI: B-ISGMB-402DD
Reference: ISGMB-402
EMDN: W0105040308
EMDN description: HSV 2 ANTIBODIES - TOTAL
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella IgM Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRM-302VE
Basic UDI-DI: B-IRM-302VE
Reference: IRM-302
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCP-R502AN
Basic UDI-DI: B-INCP-R502AN
Reference: INCP-R502
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

CMV IgM Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICM-302PB
Basic UDI-DI: B-ICM-302PB
Reference: ICM-302
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Astrovirus Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IAS-R602DB
Basic UDI-DI: B-IAS-R602DB
Reference: IAS-R602
EMDN: W0105040629
EMDN description: ASTROVIRUS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 (COVID-19) Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCP-G50289
Basic UDI-DI: B-INCP-G50289
Reference: INCP-G502
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCP-502-NWT
Basic UDI-DI: B-INCP-502-NWT
Reference: INCP-502-N
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICOV-R802DE
Basic UDI-DI: B-ICOV-R802DE
Reference: ICOV-R802
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test (Corona Lollipop Rapid Test)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICOV-804K3
Basic UDI-DI: B-ICOV-804K3
Reference: ICOV-804
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step SARS-CoV-2 (COVID-19) Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICOV-803JZ
Basic UDI-DI: B-ICOV-803JZ
Reference: ICOV-803
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-NCP-802TB
Basic UDI-DI: B-FI-NCP-802TB
Reference: FI-NCP-802
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:32

Manufacturer products Authorised representative products Authorised representative actors View details