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66 device results listed.

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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

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 products Authorised representative products Authorised representative actors View details

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

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

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

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IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006653
Basic UDI-DI: 8905459MHVWRPDJX
Reference: HVWRPD-11
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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006660
Basic UDI-DI: 8905459MHVWRPDJX
Reference: HVWRPD-12
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 products Authorised representative products Authorised representative actors Open in EUDAMED View details

Artron HlV, HBsAg & HCV Combo Test

Cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561062
Basic UDI-DI: B-00628347561062
Reference: A02-20-222
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test

Cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561024
Basic UDI-DI: B-00628347561024
Reference: A02-07-222
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0629U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001686
Basic UDI-DI: B-00608337001686
Reference: 1001-0629U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0602U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001525
Basic UDI-DI: B-00608337001525
Reference: 1001-0602U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0601U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001518
Basic UDI-DI: B-00608337001518
Reference: 1001-0601U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0600U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001273
Basic UDI-DI: B-00608337001273
Reference: 1001-0600U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class DIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459004741
Basic UDI-DI: 8905459HIVWBSFEL
Reference: HIVWBS-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: 03.07.2026 22:44

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

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IVD Class DIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459004758
Basic UDI-DI: 8905459HIVWBSFEL
Reference: HIVWBS-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: 03.07.2026 22:44

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

-

IVD Class DIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459004765
Basic UDI-DI: 8905459HIVWBSFEL
Reference: HIVWBS-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: 03.07.2026 22:44

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

HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-12

IVD Class DIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074564327
Basic UDI-DI: 8905459MHVWRPDJX
Reference: HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 , 08, 09, 10, 11, 12
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Netherlands
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/012 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

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