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Xpert®

Xpert® Xpress CoV-2/Flu/RSV plus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008000
Basic UDI-DI: B-07332940008000
Reference: XP3COV2/FLU/RSV-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNVC-CED-02X4

Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-02X4
Basic UDI-DI: B-TD-HNVC-CED-02X4
Reference: /
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel 21 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP23021VA5
Basic UDI-DI: B-RP23021VA5
Reference: RP23021V
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP13MA
Basic UDI-DI: B-RP13MA
Reference: RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 2

RP2-P7-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP2-P7-10YM
Basic UDI-DI: B-RP2-P7-10YM
Reference: RP2-P7-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 1.0

RP1-P10-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP1-P10-10NG
Basic UDI-DI: B-RP1-P10-10NG
Reference: RP1-P10-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Influenza A/B and RSV Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP03M7
Basic UDI-DI: B-RP03M7
Reference: RP03021X, RP03022X, RP03023W
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 1.1

RP-P10-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP-P10-10XX
Basic UDI-DI: B-RP-P10-10XX
Reference: RP-P10-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90508ZM

Influenza & SARS-CoV-2 Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90508ZM
Basic UDI-DI: B-K90508ZM
Reference: /
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Comprehensive Respiratory Virus Panel

G2MCRVP17001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MCRVP17001A4
Basic UDI-DI: B-G2MCRVP17001A4
Reference: G2MCRVP17001-ill, G2MCRVP17001-TF
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/FluA/FluB/RSV Test

Cov2P4-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-Cov2P4-10HND5
Basic UDI-DI: B-Cov2P4-10HND5
Reference: Cov2P4-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test

CoV2-20

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-CoV2-207D
Basic UDI-DI: B-CoV2-207D
Reference: CoV2-20
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test

CoV2-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-CoV2-107A
Basic UDI-DI: B-CoV2-107A
Reference: CoV2-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Respiratory-24 Pathogen Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: D-8684387210188CU
Basic UDI-DI: B-8684387210188CU
Reference: IP202323
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Slovakia
Authorised representative: -
Last updated: 12.07.2026 17:27

Manufacturer products View details

SirYus Covidiag +

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substances

Manufacturer: Innobiochips
Manufacturer SRN: FR-MF-000009584
UDI-DI: 37700267940128
Basic UDI-DI: B-37700267940128
Reference: 2009
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:50

Manufacturer products View details

SirYus Covidiag

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substances

Manufacturer: Innobiochips
Manufacturer SRN: FR-MF-000009584
UDI-DI: 37700267940050
Basic UDI-DI: B-37700267940050
Reference: 2001
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:50

Manufacturer products View details

EasyScreen

EasyScreen® SARS CoV-2 Detection Kit

IVD generalIVDDNo longer on the marketInstrumentKitReagentSingle use

Manufacturer: Genetic Signatures Ltd
Manufacturer SRN: AU-MF-000030901
UDI-DI: 09351179002090
Basic UDI-DI: B-09351179002090
Reference: RP012-HT
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: mdi Europa GmbH
Last updated: 10.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

EasyScreen

EasyScreen Respiratory Pathogen Detection Kit (RP007)

IVD generalIVDDNo longer on the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: Genetic Signatures Ltd
Manufacturer SRN: AU-MF-000030901
UDI-DI: 09351179002021
Basic UDI-DI: B-09351179002021
Reference: RP007-HT
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 10.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 1

RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044007118
Basic UDI-DI: B-09343044007118
Reference: 80081S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 2

RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044007101
Basic UDI-DI: B-09343044007101
Reference: 80081P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details