Public EUDAMED Search

EUDAMED Device Search

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

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17.07.2026 04:53

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Active filter:Manufacturer SRN:AU-MF-000024146

9 device results listed.

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09349609001126

ARST001-04

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609001126
Basic UDI-DI: B-09349609001126
Reference: ARST001-04
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609001140

ARST001-05

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609001140
Basic UDI-DI: B-09349609001140
Reference: ARST001-05
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609001102

NFLD001-03

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609001102
Basic UDI-DI: B-09349609001102
Reference: NFLD001-03
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609000969

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000969
Basic UDI-DI: B-09349609000969
Reference: NFLD001-02
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609000952

NFLD001-02

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000952
Basic UDI-DI: B-09349609000952
Reference: NFLD001-02
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Newfoundland HIV Self Test

NFLD001-01

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000938
Basic UDI-DI: B-09349609000938
Reference: NFLD001-01
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Simplitude ByMe

Galileo Platform

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000600
Basic UDI-DI: B-09349609000600
Reference: P003948A1-10
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Simplitude ByMe

Galileo Platform

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000204
Basic UDI-DI: B-09349609000204
Reference: P002514A1-10
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609000082

ARST001-02

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000082
Basic UDI-DI: B-09349609000082
Reference: ARST001-02
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details