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06975068491074

25Tests/kit

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491074
Basic UDI-DI: B-06975068491074
Reference: CP109.B1
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.08.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

RESPIRATORY SYNCYTIAL VIRUS ELISA IgG/IgM

G/M1006

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320426
Basic UDI-DI: B-08436040320426
Reference: G/M1006
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

06955792743427

Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743427
Basic UDI-DI: B-06955792743427
Reference: S3347E-50
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743410

Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743410
Basic UDI-DI: B-06955792743410
Reference: S3347E-25
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743403

Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743403
Basic UDI-DI: B-06955792743403
Reference: S3347E-1
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRS-R502N7
Basic UDI-DI: B-IRS-R502N7
Reference: IRS-R502
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test（Swab）

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840313222
Basic UDI-DI: B-69743840313222
Reference: 3022001
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

RSV-Q Real Time PCR Kit

G2M801221

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M801221ER
Basic UDI-DI: B-G2M801221ER
Reference: G2M801221, G2M801221R
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescent Rapid Test Cassette (Swab)

FCRSV-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRSV-502aHGKS
Basic UDI-DI: B-FCRSV-502aHGKS
Reference: FCRSV-502a
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-FCRSV-502aEE

RSV Antigen Fluorescent Rapid Test Cassette (Swab)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRSV-502aEE
Basic UDI-DI: B-FCRSV-502aEE
Reference: FCRSV-502a
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescence Rapid Test Cassette (Swab)

FCRSV-502Ca

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRSV-502CaHGU8
Basic UDI-DI: B-FCRSV-502CaHGU8
Reference: FCRSV-502Ca
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescence Rapid Test Cassette (Swab)

FCRSV-502Ca

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRSV-502CaCW
Basic UDI-DI: B-FCRSV-502CaCW
Reference: FCRSV-502Ca
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4403017FN

SARS-CoV-2 Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4403017FN
Basic UDI-DI: B-EIM4403017FN
Reference: EIM4403017
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Respiratory Syncytial Virus Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A014CS
Basic UDI-DI: B-A014CS
Reference: INDICAID™ Respiratory Syncytial Virus Rapid Antigen Test
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® Respiratory syncytial virus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R12EJ
Basic UDI-DI: B-1R12EJ
Reference: 1R12
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

Manufacturer products View details

Pluslife RSV Card

RSV Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120202
Basic UDI-DI: B-06975327120202
Reference: RM1010902-10
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus (RSV) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854621497
Basic UDI-DI: B-06974854621497
Reference: P22095
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302943
Basic UDI-DI: B-06974566302943
Reference: RSV-402
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911077
Basic UDI-DI: B-06974238911077
Reference: HRSV022G
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Ag Rapid Test Kit

A02108002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683580
Basic UDI-DI: B-06973861683580
Reference: A02108002
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details