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

22.09.2026 11:56

Sync status

Successful

Device

3537119

Actor

47728

Certificate

3381

Filters

Show filters

Active filter:EMDN:W0105030402

57 device results listed.

Page 2 / 3

CSV XML

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

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-015 and 90-1015-016

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202067
Basic UDI-DI: B-00686597202067
Reference: 90-1015-015 and 90-1015-016
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1026-001

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201947
Basic UDI-DI: B-00686597201947
Reference: 90-1026-001
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-019 and 90-1028-020

IVD Annex II List AIVDDOn the marketKitProfessional testingSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201831
Basic UDI-DI: B-00686597201831
Reference: 90-1028-019 and 90-1028-020
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1026-002

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201824
Basic UDI-DI: B-00686597201824
Reference: 90-1026-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV Self Test (no pipette variant, packaged in a pouch)

90-1041-014 and 90-1041-015

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201794
Basic UDI-DI: B-00686597201794
Reference: 90-1041-014 and 90-1041-015
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV Self Test (no pipette variant, packaged in pouch)

90-1041-012 and 90-1041-013

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201770
Basic UDI-DI: B-00686597201770
Reference: 90-1041-012 and 90-1041-013
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1026-003

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201763
Basic UDI-DI: B-00686597201763
Reference: 90-1026-003
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-013 and 90-1015-014

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201664
Basic UDI-DI: B-00686597201664
Reference: 90-1015-013 and 90-1015-014
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1126-001 and 90-1126-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201244
Basic UDI-DI: B-00686597201244
Reference: 90-1126-001 and 90-1126-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1123-001

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200889
Basic UDI-DI: B-00686597200889
Reference: 90-1123-001
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

90-1026

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200858
Basic UDI-DI: B-00686597200858
Reference: 90-1026
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1058-001 and 90-1058-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200612
Basic UDI-DI: B-00686597200612
Reference: 90-1058-001 and 90-1058-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSïl HIV Self Test (no pipette variant, packaged in a box)

90-1057-001 and 90-1057-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200599
Basic UDI-DI: B-00686597200599
Reference: 90-1057-001 and 90-1057-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

INSïl HIV Self Test (no pipette variant, packaged in a box)

90-1056-001 and 90-1056-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200575
Basic UDI-DI: B-00686597200575
Reference: 90-1056-001 and 90-1056-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV Self Test (no pipette variant, packaged in a pouch)

90-1041-007

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200568
Basic UDI-DI: B-00686597200568
Reference: 90-1041-007
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details