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

01.08.2026 12:34

Sync status

Successful

Device

2989310

Actor

47520

Certificate

3174

Filters

Show filters

Active filter:EMDN:W010503

91 device results listed.

Page 1 / 5

CSV XML

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-017 and 90-1015-018

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

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202173
Basic UDI-DI: B-00686597202173
Reference: 90-1015-017 and 90-1015-018
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1060-001, 90-1060-002, 90-1060-003, and 90-1060-004

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201466
Basic UDI-DI: B-00686597201466
Reference: 90-1060-001, 90-1060-002, 90-1060-003 and 90-1060-004
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1076-005 and 90-1076-006

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201428
Basic UDI-DI: B-00686597201428
Reference: 90-1076-005 and 90-1076-006
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1076-003 and 90-1076-004

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201404
Basic UDI-DI: B-00686597201404
Reference: 90-1076-003 and 90-1076-004
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1059-001 and 90-1059-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200636
Basic UDI-DI: B-00686597200636
Reference: 90-1059-001 and 90-1059-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-010

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

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200414
Basic UDI-DI: B-00686597200414
Reference: 90-1015-010
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1076

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010761
Basic UDI-DI: B-00686597010761
Reference: 90-1076
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1063

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010631
Basic UDI-DI: B-00686597010631
Reference: 90-1063
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1060

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010600
Basic UDI-DI: B-00686597010600
Reference: 90-1060
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1059

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010594
Basic UDI-DI: B-00686597010594
Reference: 90-1059
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1058

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010587
Basic UDI-DI: B-00686597010587
Reference: 90-1058
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1057

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010570
Basic UDI-DI: B-00686597010570
Reference: 90-1057
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010563
Basic UDI-DI: B-00686597010563
Reference: 90-1056
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010501
Basic UDI-DI: B-00686597010501
Reference: 90-1050
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

EIAgen Detect HIV Combo Kit

++M52108131C

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52108131CB3
Basic UDI-DI: B-++M52108131CB3
Reference: 081311C / 081312C / 081315C
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Hungary
Authorised representative: -
Last updated: 01.08.2026 01:56

Manufacturer products View details

Merilisa

HV4ELI - 05

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074569438
Basic UDI-DI: B-18906074569438
Reference: HV4ELI - 05
EMDN: W0105030302
EMDN description: HIV P24 ANTIBODY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI - 09

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001665
Basic UDI-DI: B-08905459001665
Reference: HV4ELI - 09
EMDN: W0105030302
EMDN description: HIV P24 ANTIBODY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

Merilisa

HV4ELI – 08

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001269
Basic UDI-DI: B-08905459001269
Reference: HV4ELI – 08
EMDN: W0105030301
EMDN description: HIV P24 ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 29.07.2026 11:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-Z133825S

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z133825S
Basic UDI-DI: B-Z133825S
Reference: Z13382
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:52

Manufacturer products View details

D-Z043805J

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z043805J
Basic UDI-DI: B-Z043805J
Reference: Z04380
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details