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62 device results listed.

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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: 08693285182718
Basic UDI-DI: B-08693285182718
Reference: RTHIV02
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

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: 08693285182633
Basic UDI-DI: B-08693285182633
Reference: THIV02
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

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: 08693285181308
Basic UDI-DI: B-08693285181308
Reference: IHIV01
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

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: 08693285181186
Basic UDI-DI: B-08693285181186
Reference: RTHIV01
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

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 products View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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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 products Authorised representative products Authorised representative actors Open in EUDAMED View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details