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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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19.09.2026 15:33

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96 device results listed.

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Sentosa SQ HIV Genotyping Assay (4x16)

690037

IVD Annex II List AIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956610
Basic UDI-DI: B-08885013956610
Reference: 690037
EMDN: W0105030108
EMDN description: HIV 1 GENOTYPING - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740058
Basic UDI-DI: B-08698898740058
Reference: M0290202
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

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RevoDx HIV-1 qPCR Kit

RevoDx HIV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215657
Basic UDI-DI: B-08684387215657
Reference: IP201924-100
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

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RevoDx HIV-1 qPCR Kit

RevoDx HIV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215640
Basic UDI-DI: B-08684387215640
Reference: IP201924-25
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

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RevoDx HIV-2 qPCR Kit

RevoDx HIV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215114
Basic UDI-DI: B-08684387215114
Reference: IP202236-100
EMDN: W0105030204
EMDN description: HIV 2 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HIV-2 qPCR Kit

RevoDx HIV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215107
Basic UDI-DI: B-08684387215107
Reference: IP202236-25
EMDN: W0105030204
EMDN description: HIV 2 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HIV-1/2 qPCR Kit

RevoDx HIV-1/2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212175
Basic UDI-DI: B-08684387212175
Reference: IP202238-100
EMDN: W0105030405
EMDN description: HIV MULTIPLE - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-1/2 qPCR Kit

RevoDx HIV-1/2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212168
Basic UDI-DI: B-08684387212168
Reference: IP202238-25
EMDN: W0105030405
EMDN description: HIV MULTIPLE - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-2 qPCR Kit

RevoDx HIV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212137
Basic UDI-DI: B-08684387212137
Reference: IP202237-100
EMDN: W0105030204
EMDN description: HIV 2 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-2 qPCR Kit

RevoDx HIV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212120
Basic UDI-DI: B-08684387212120
Reference: IP202237-25
EMDN: W0105030204
EMDN description: HIV 2 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-1 qPCR Kit

RevoDx HIV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212076
Basic UDI-DI: B-08684387212076
Reference: IP201903-250
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-1 qPCR Kit

RevoDx HIV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212069
Basic UDI-DI: B-08684387212069
Reference: IP201903-100
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-1 qPCR Kit

RevoDx HIV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212052
Basic UDI-DI: B-08684387212052
Reference: IP201903-50
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HIV-1 qPCR Kit

RevoDx HIV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212045
Basic UDI-DI: B-08684387212045
Reference: IP201903-25
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

TaqPath™ Menu | GeneProof™ HIV type 1 (HIV-1) Diagnostic PCR Kit

GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696303976
Basic UDI-DI: B-08595696303976
Reference: A58119
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit

GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300821
Basic UDI-DI: B-08595696300821
Reference: HIV1D/GP/100
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:57

Manufacturer products View details

GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit

GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300807
Basic UDI-DI: B-08595696300807
Reference: HIV1D/GP/025
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:57

Manufacturer products 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