Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

21.09.2026 00:14

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3283

Filters

Show filters

Active filter:EMDN:W01050903

76 device results listed.

Page 4 / 4

CSV XML

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

08905459004741

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

08905459004758

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

08905459004765

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

MERISCREEN

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

Artron HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Artron 3H Combo Test)

Cassette

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561079
Basic UDI-DI: 62834756AL0220026A
Reference: A02-20-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-3H Combo-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

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

Artron Human Immunodeficiency Virus (HIV 1/2) Antibody Test

Cassette

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561031
Basic UDI-DI: 62834756AL0207026X
Reference: A02-07-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-HIV Ab(WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

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

06952999407497

IHI-T402

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999407497
Basic UDI-DI: B-06952999407497
Reference: IHI-T402
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:51

Manufacturer products Authorised representative products Authorised representative actors View details

HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Device

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810726
Basic UDI-DI: B-06952804810726
Reference: HIV-W23
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561048
Basic UDI-DI: 62834756AL0207026X
Reference: AM02-07-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-HIV Ab(WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

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

Acmex HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Acmex 3H Combo Test)

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561086
Basic UDI-DI: 62834756AL0220026A
Reference: AM02-20-322P25
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-3H Combo-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

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