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VIRAPID® RESPIRATORY SYNCYTIAL VIRUS Ag FIA

VRF003

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290784
Basic UDI-DI: 843661029VRF00301R3
Reference: VRF003
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

Simple RSV

9.064.XXX.YY.ZZZ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003191
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.46.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

05902643958548

RSV + Adeno-resp. - kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958548
Basic UDI-DI: 59026439BRT342JL
Reference: 1-342-K020
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

05902643958432

RSV - kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958432
Basic UDI-DI: 59026439BRT326JN
Reference: 1-326-K020
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

Accu-Tell® RSV Antigen Cassette (Swab)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432252
Basic UDI-DI: B-06970581432252
Reference: ABT-IDT-B296
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702712
Basic UDI-DI: B-06954414702712
Reference: /
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Nasal test Kit

RSV-W35

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803308
Basic UDI-DI: B-06952804803308
Reference: RSV-W35
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

RSV FIA

RSV-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802875
Basic UDI-DI: B-06952804802875
Reference: RSV-S23F3
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test Cassette (Swab)

GCRSV-502a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002431
Basic UDI-DI: B-06950996002431
Reference: GCRSV-502a
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210227
Basic UDI-DI: B-06937339210227
Reference: VIRS-701
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209986
Basic UDI-DI: B-06937339209986
Reference: VIRS-702
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205407
Basic UDI-DI: B-06937339205407
Reference: VIRS-702
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339203229
Basic UDI-DI: B-06937339203229
Reference: VIRS-702
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® RSV Ag Rapid Test

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

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00855402007597
Basic UDI-DI: 081011446R0186CEN
Reference: R0186C
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Atlas

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658551910
Basic UDI-DI: B-04260658551910
Reference: 8.16.39.0.0020
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:34

Manufacturer products View details

Simple RSV

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004792
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.71.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple RSV

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007908
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.16.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple RSV

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577119113
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.15.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details