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04262386730162

RoboGene HDV RNA Quantification Kit 2.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730162
Basic UDI-DI: B-04262386730162
Reference: 847-0207400544
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:39

Manufacturer products View details

04262386730155

RoboGene HDV RNA Quantification Kit 2.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730155
Basic UDI-DI: B-04262386730155
Reference: 847-0207400542
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:38

Manufacturer products View details

04262386730148

RoboGene HDV RNA Quantification Kit 2.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730148
Basic UDI-DI: B-04262386730148
Reference: 847-0207400584
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:38

Manufacturer products View details

04262386730131

RoboGene HDV RNA Quantification Kit 2.0

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Roboscreen GmbH
Manufacturer SRN: DE-MF-000024661
UDI-DI: 04262386730131
Basic UDI-DI: B-04262386730131
Reference: 847-0207400582
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:38

Manufacturer products View details

HEPATITIS DELTA REALTIME PCR KIT

RTPCR017

IVD Class DIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290043
Basic UDI-DI: 843661029RTPCR017018R
Reference: RTPCR017-LP
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Spain
Safety summary (SSCP/SSP): RTPCR017 · Rev. 8
Authorised representative: -
Last updated: 16.07.2026 12:22

Manufacturer products Open in EUDAMED View details

Fluorion

Fluorion HDV QNP 1.0 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: 08698898740621
Basic UDI-DI: B-08698898740621
Reference: M0060202
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

RevoDx HDV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212113
Basic UDI-DI: B-08684387212113
Reference: IP202230-250
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HDV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212106
Basic UDI-DI: B-08684387212106
Reference: IP202230-100
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HDV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212090
Basic UDI-DI: B-08684387212090
Reference: IP202230-50
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

RevoDx HDV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212083
Basic UDI-DI: B-08684387212083
Reference: IP202230-25
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:52

Manufacturer products View details

LyoSens HDV Detection qPCR Kit

LYO45

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259714
Basic UDI-DI: B-08683548259714
Reference: LYO45
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

Manufacturer products View details

ChainFor HDV Detection qPCR Kit

CFP72

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257727
Basic UDI-DI: B-08683548257727
Reference: CFP72
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details