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EUDAMED Device Search

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

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05.07.2026 13:56

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49 device results listed.

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Cassette

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568085
Basic UDI-DI: B-00628347568085
Reference: A01-02-122MT1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568061
Basic UDI-DI: B-00628347568061
Reference: A01-04-130AK2
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Denmark
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

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THE NEW Test Days

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IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568047
Basic UDI-DI: B-00628347568047
Reference: A01-04-130NTD1
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

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Artron Fecal Occult Blood (FOB)Test

cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347564094
Basic UDI-DI: B-00628347564094
Reference: A05-02-422
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

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Artron Artron Multi-Drug Dip Card Test

Dip Card

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347563783
Basic UDI-DI: B-00628347563783
Reference: A04-18-140
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 17:22

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Artron Procalcitonin (PCT) Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561796
Basic UDI-DI: B-00628347561796
Reference: A03-23-222
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

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Artron Dengue NS1 Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561604
Basic UDI-DI: B-00628347561604
Reference: A03-22-222
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

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Artron ONE STEP Tuberculosis Antibody (TB Ab) Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561383
Basic UDI-DI: B-00628347561383
Reference: A03-07-222
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 17:22

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Artron Helicobacter pylori (HP) Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561222
Basic UDI-DI: B-00628347561222
Reference: A02-11-422
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

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Artron Helicobacter Pylori (HP) Antibody Test

cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561178
Basic UDI-DI: B-00628347561178
Reference: A02-11-222
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

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Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561123
Basic UDI-DI: B-00628347561123
Reference: A02-09-322
EMDN: W0105090105
EMDN description: SYPHILIS - 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 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 One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561116
Basic UDI-DI: B-00628347561116
Reference: A02-09-222
EMDN: W0105090105
EMDN description: SYPHILIS - 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 One Step Treponema Pallidum (TP) Antibody Test

Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561109
Basic UDI-DI: B-00628347561109
Reference: A02-09-213
EMDN: W0105090105
EMDN description: SYPHILIS - 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

Artron Hepatitis C Virus (HCV) Antibody Test

cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560973
Basic UDI-DI: B-00628347560973
Reference: A02-06-222
EMDN: W0105090202
EMDN description: HCV ANTIBODY -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 Hepatitis B Virus Surface Antigen (HBsAg) Test

Cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560874
Basic UDI-DI: B-00628347560874
Reference: A02-01-222
EMDN: W0105090201
EMDN description: HBSAG - 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 Chorionic Gonadotropin (HCG) Test For self-testing(Ultra Sensitivity)

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560478
Basic UDI-DI: B-00628347560478
Reference: A01-02-130
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Onestep Pregnancy Urine Tests for Self- testing (Regular)

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560454
Basic UDI-DI: B-00628347560454
Reference: A01-01-130
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex Treponema Pallidum (TP) Antibody Test

Cassette

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561093
Basic UDI-DI: 62834756AL02090279
Reference: AM02-09-322P
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-TP Ab(WB)-2024 · Rev. 06
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