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EUDAMED Device Search

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TREN

Last updated

22.09.2026 11:56

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3537178

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Certificate

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Active filter:EMDN:W0105099002

67 device results listed.

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RSV Antigen Rapid Test Cassette (ColloidalGold)

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000044128
UDI-DI
06977698400563
Basic UDI-DI
B-06977698400563
Reference
GKPD022
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
07.07.2026 01:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold)

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
BIOBASE POCT CO.,LTD
Manufacturer SRN
CN-MF-000045945
UDI-DI
06976374752507
Basic UDI-DI
B-06976374752507
Reference
25 tests / kit（DR100-4）
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
07.07.2026 00:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold)

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
BIOBASE POCT CO.,LTD
Manufacturer SRN
CN-MF-000045945
UDI-DI
06976374752491
Basic UDI-DI
B-06976374752491
Reference
20 tests / kit（DR100-3）
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
07.07.2026 00:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RSV FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000022829
UDI-DI
06974674892350
Basic UDI-DI
B-06974674892350
Reference
18-02-0065
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Netherlands
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:14
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000024149
UDI-DI
06974521005698
Basic UDI-DI
B-06974521005698
Reference
SUPF062025
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Ireland
Authorised representative
QbD RepS BV
Last updated
06.07.2026 19:43
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)

Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000024149
UDI-DI
06974521001966
Basic UDI-DI
B-06974521001966
Reference
SUPL022025
EMDN
W0105099002
EMDN description
RSV - RT & POC
First on market country
Ireland
Authorised representative
QbD RepS BV
Last updated
06.07.2026 19:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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 productsView 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 productsView 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 productsView 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 productsView details
RSV Fast Test Kit (Immunofluorescence Assay)

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details