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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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01.08.2026 18:27

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Cassette

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568160
Basic UDI-DI: B-00628347568160
Reference: A01-06-422VF1
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

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Midstream

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568153
Basic UDI-DI: B-00628347568153
Reference: A01-03-130VF5
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

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Midstream

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568146
Basic UDI-DI: B-00628347568146
Reference: A01-03-130MT1
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

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Midstream

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568139
Basic UDI-DI: B-00628347568139
Reference: A01-02-130MT1
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

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Cassette

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568122
Basic UDI-DI: B-00628347568122
Reference: A01-06-422AK1
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Denmark
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

Cassette

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568115
Basic UDI-DI: B-00628347568115
Reference: A01-06-422AF1
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

Midstream

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568108
Basic UDI-DI: B-00628347568108
Reference: A01-04-130FL2
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

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Cassette

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568092
Basic UDI-DI: B-00628347568092
Reference: A01-06-422BS1
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

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

Midstream

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

Manufacturer products Authorised representative products Authorised representative actors View details

THE NEW Test Days

Midstream

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

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

Fortel Ultra Sensitive Pregnancy Midstream 2-Test

1147-02

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingSelf testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059114720
Basic UDI-DI: B-00083059114720
Reference: 1147-02
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel Ultra Sensitive Pregnancy Midstream 1-Test

1147-01

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingSelf testingSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059114713
Basic UDI-DI: B-00083059114713
Reference: 1147-01
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel Ovulation Prediction Test

-

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059012514
Basic UDI-DI: B-00083059012514
Reference: 1251
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Pregnancy Test Ultra Early

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IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001090036629
Basic UDI-DI: 4084500CB14QT
Reference: 08001090036629
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 04:54

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Pregnancy Test Ultra Early

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001090036667
Basic UDI-DI: 4084500CB14QT
Reference: 08001090036667
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 04:54

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Test di gravidanza Rilevazione Precoce

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IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001090036742
Basic UDI-DI: 4084500CB14QT
Reference: 08001090036742
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 04:54

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Test de grossesse Détection Ultra Précoce

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IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001090039538
Basic UDI-DI: 4084500CB14QT
Reference: 08001090039538
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 04:54

Manufacturer products Authorised representative products Authorised representative actors View details