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78 device results listed.

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autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742264
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-001 ; AS-VIH-008
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 21.09.2026 21:16

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autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746Not intended for EU marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 07640128450290
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-009
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 21.09.2026 21:10

Manufacturer products Open in EUDAMED View details

CupiKIT

HIV 1 & 2 Antibody Test Kit

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Cupid Limited
Manufacturer SRN: IN-MF-000033199
UDI-DI: 08906005286055
Basic UDI-DI: 890600528cuphiv1229
Reference: CUPHIV-01
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Austria
Safety summary (SSCP/SSP): QA/090/F-04 · Rev. 01
Authorised representative: Amstermed B.V.
Last updated: 04.08.2026 22:48

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

OraQuick HIV Self-Test

1001-0628

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001676
Basic UDI-DI: B-10608337001676
Reference: 1001-0628
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

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OraQuick HIV Self-Test

1001-0627

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001669
Basic UDI-DI: B-10608337001669
Reference: 1001-0627
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

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OraQuick HIV Self-Test

1001-0603

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001539
Basic UDI-DI: B-10608337001539
Reference: 1001-0603
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

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OraQuick HIV Self-Test

1001-0601

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001515
Basic UDI-DI: B-10608337001515
Reference: 1001-0601
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Portugal
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

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OraQuick HIV Self-Test

1001-0600

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001270
Basic UDI-DI: B-10608337001270
Reference: 1001-0600
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

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OraQuick HIV Self-Test

1001-0630

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001065
Basic UDI-DI: B-10608337001065
Reference: 1001-0630
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

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MP Diagnostics MULTISURE HIV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000665
Basic UDI-DI: B-08887581000665
Reference: 43030-020
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

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HIV 1.2 Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106030
Basic UDI-DI: B-06936983106030
Reference: IHI-402
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

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04571226473832

Determine HIV Early Detect

IVD Annex II List AIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226473832
Basic UDI-DI: B-04571226473832
Reference: 7D2846
EMDN: W0105090303
EMDN description: HIV AG/AB COMBI - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

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OraQuick HIV Self-Test

1001-0628U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001679
Basic UDI-DI: B-00608337001679
Reference: 1001-0628U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

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OraQuick HIV Self-Test

1001-0603U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001532
Basic UDI-DI: B-00608337001532
Reference: 1001-0603U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0630U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001068
Basic UDI-DI: B-00608337001068
Reference: 1001-0630U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

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OraQuick HIV Self-Test

1001-0627U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001662
Basic UDI-DI: B-00608337001662
Reference: 1001-0627U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

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HIVFIND

HIVSST-01

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSterile

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001672
Basic UDI-DI: 8905459HIVOSF9V
Reference: HIVSST-01
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

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

Wondfo

Wondfo One Step HIV1/2 Whole Blood/Serum/Plasma Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289817905
Basic UDI-DI: B-06933289817905
Reference: W752-C4G3-E
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

08905459001689

HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04

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

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001689
Basic UDI-DI: 8905459HIVWBSFEL
Reference: HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Austria
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

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08905459001191

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

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

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001191
Basic UDI-DI: 8905459MHVWRPDJX
Reference: HVWRPD-07
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/012 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

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