Public EUDAMED Search

EUDAMED Device Search

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

Last updated

06.07.2026 15:04

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Successful

Device

2680564

Actor

47323

Certificate

3038

Active filter:Manufacturer SRN:CA-MF-000023304

52 device results listed.

Page 3 / 3

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-003 and 90-1015-004

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200353
Basic UDI-DI
B-00686597200353
Reference
90-1015-003 and 90-1015-004
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
INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-001 and 90-1015-002

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200339
Basic UDI-DI
B-00686597200339
Reference
90-1015-001 and 90-1015-002
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
INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-011 and 90-1028-012

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200278
Basic UDI-DI
B-00686597200278
Reference
90-1028-011 and 90-1028-012
EMDN
W0105010302
EMDN description
SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
04.07.2026 18:03
INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-011 and 90-1015-012

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use
Manufacturer
bioLytical Laboratories Inc.
Manufacturer SRN
CA-MF-000023304
UDI-DI
00686597200193
Basic UDI-DI
B-00686597200193
Reference
90-1015-011 and 90-1015-012
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