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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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Trichinella spiralis IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Bordier Affinity Products SA
Manufacturer SRN: CH-MF-000025247
UDI-DI: 07640158219751
Basic UDI-DI: 76401582197503H
Reference: 9750
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: France
Authorised representative: Leman Diagnostics SARL
Last updated: 01.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

Anisakidae IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Bordier Affinity Products SA
Manufacturer SRN: CH-MF-000025247
UDI-DI: 07640158219805
Basic UDI-DI: 764015821980037
Reference: 9800
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: France
Authorised representative: Leman Diagnostics SARL
Last updated: 01.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

OraQuick HIV Self-Test

1001-0628U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001679
Basic UDI-DI: B-00608337001679
Reference: 1001-0628U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0603U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001532
Basic UDI-DI: B-00608337001532
Reference: 1001-0603U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0630U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001068
Basic UDI-DI: B-00608337001068
Reference: 1001-0630U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0627U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001662
Basic UDI-DI: B-00608337001662
Reference: 1001-0627U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details