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Last updated

22.09.2026 08:45

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Active filter:EMDN:W01050903

78 device results listed.

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08693285181063

Anti-HIV 1/2 Test

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use
Manufacturer
TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN
TR-MF-000028553
UDI-DI
08693285181063
Basic UDI-DI
B-08693285181063
Reference
THIV01
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 06:25
Manufacturer productsView details
06940131404992

-

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use
Manufacturer
NewScen Coast Bio-Pharmaceutical Co.,Ltd.
Manufacturer SRN
CN-MF-000021934
UDI-DI
06940131404992
Basic UDI-DI
69401314HIV002CG
Reference
HIV3-29202511000
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
ZXKJ-CE-02-9 · Rev. Rev. A/4
Authorised representative
Wellkang Ltd
Last updated
08.07.2026 23:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
06940131405005

-

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use
Manufacturer
NewScen Coast Bio-Pharmaceutical Co.,Ltd.
Manufacturer SRN
CN-MF-000021934
UDI-DI
06940131405005
Basic UDI-DI
69401314HIV002CG
Reference
HIV3-29204017000
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
ZXKJ-CE-02-9 · Rev. Rev. A/4
Authorised representative
Wellkang Ltd
Last updated
08.07.2026 23:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
06940131405012

-

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use
Manufacturer
NewScen Coast Bio-Pharmaceutical Co.,Ltd.
Manufacturer SRN
CN-MF-000021934
UDI-DI
06940131405012
Basic UDI-DI
69401314HIV002CG
Reference
HIV3-29200501000
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
ZXKJ-CE-02-9 · Rev. Rev. A/4
Authorised representative
Wellkang Ltd
Last updated
08.07.2026 23:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
06940131405098

-

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use
Manufacturer
NewScen Coast Bio-Pharmaceutical Co.,Ltd.
Manufacturer SRN
CN-MF-000021934
UDI-DI
06940131405098
Basic UDI-DI
69401314HIV002CG
Reference
HIV3-29200201000
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
ZXKJ-CE-02-9 · Rev. Rev. A/4
Authorised representative
Wellkang Ltd
Last updated
08.07.2026 23:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
HIVFIND

-

IVD Class DNot specifiedOn the marketAnimal tissuesDirect markingKitSelf testingSterile
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459004710
Basic UDI-DI
8905459HIVOSF9V
Reference
HIVSST-02
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative
Obelis s.a.
Last updated
08.07.2026 00:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
HIVFIND

-

IVD Class DNot specifiedOn the marketAnimal tissuesDirect markingKitSelf testingSterile
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459004727
Basic UDI-DI
8905459HIVOSF9V
Reference
HIVSST-03
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative
Obelis s.a.
Last updated
08.07.2026 00:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
HIVFIND

-

IVD Class DNot specifiedOn the marketAnimal tissuesDirect markingKitSelf testingSterile
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459004734
Basic UDI-DI
8905459HIVOSF9V
Reference
HIVSST-04
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative
Obelis s.a.
Last updated
08.07.2026 00:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)

100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000022829
UDI-DI
06974674891421
Basic UDI-DI
B-06974674891421
Reference
18-02-0034
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 20:11
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000022829
UDI-DI
06974674891414
Basic UDI-DI
B-06974674891414
Reference
18-02-0033
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 20:11
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000022829
UDI-DI
06974674891407
Basic UDI-DI
B-06974674891407
Reference
18-02-0032
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 20:11
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Ebola Virus Antigen Rapid Test Kit

20T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use
Manufacturer
Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN
CN-MF-000047757
UDI-DI
06974443201864
Basic UDI-DI
B-06974443201864
Reference
RNPT96029-20
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hantavirus Antigen Rapid Test Kit

1T

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN
CN-MF-000047757
UDI-DI
06974443201833
Basic UDI-DI
B-06974443201833
Reference
RNPT96028-01
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hantavirus IgG/IgM Antibody Rapid Test Kit

20T

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN
CN-MF-000047757
UDI-DI
06974443201826
Basic UDI-DI
B-06974443201826
Reference
RNPT96027-20
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Cyprus
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Ebola Virus Antigen Rapid Test Kit

1T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use
Manufacturer
Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN
CN-MF-000047757
UDI-DI
06974443201857
Basic UDI-DI
B-06974443201857
Reference
RNPT96029-01
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Hantavirus IgG/IgM Antibody Rapid Test Kit

1T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use
Manufacturer
Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN
CN-MF-000047757
UDI-DI
06974443201819
Basic UDI-DI
B-06974443201819
Reference
RNPT96027-01
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Cyprus
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Measles IgG/lgM Rapid Test Kit

1T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use
Manufacturer
Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN
CN-MF-000047757
UDI-DI
06974443201758
Basic UDI-DI
B-06974443201758
Reference
RNPT96011-01
EMDN
W0105090399
EMDN description
RETROVIRUSES - RT & POC - OTHER
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 19:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
08905459001696

-

IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459001696
Basic UDI-DI
8905459MHVWRPDJX
Reference
HVWRPD-06
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CE-SSP/IM/CLD/012 · Rev. 00
Authorised representative
Obelis s.a.
Last updated
04.07.2026 22:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
08905459006639

-

IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459006639
Basic UDI-DI
8905459MHVWRPDJX
Reference
HVWRPD-09
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CE-SSP/IM/CLD/012 · Rev. 00
Authorised representative
Obelis s.a.
Last updated
04.07.2026 22:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
08905459006646

-

IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459006646
Basic UDI-DI
8905459MHVWRPDJX
Reference
HVWRPD-10
EMDN
W0105090302
EMDN description
HIV 1 / 2 - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CE-SSP/IM/CLD/012 · Rev. 00
Authorised representative
Obelis s.a.
Last updated
04.07.2026 22:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details