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32 device results listed.

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Merilisa

HPBELI-06

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001221
Basic UDI-DI: B-08905459001221
Reference: HPBELI-06
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE 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

Merilisa

HPBELI-07

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001238
Basic UDI-DI: B-08905459001238
Reference: HPBELI-07
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-Z1236059

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z1236059
Basic UDI-DI: B-Z1236059
Reference: Z12360
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Xpert®

Xpert® HBV Viral Load

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002480
Basic UDI-DI: B-07332940002480
Reference: GXHBV-VL-CE-10
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

08905459006929

RPDHBV-01 RPDHBV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006929
Basic UDI-DI: 8905459MHBSAGRTG4
Reference: RPDHBV-03
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/018 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

EIAgen HBsAg Kit

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521071045
Basic UDI-DI: B-++M521071045
Reference: 071011 / 071012 / 071015
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Hungary
Authorised representative: -
Last updated: 16.07.2026 12:48

Manufacturer products View details

Anatolia Geneworks

Bosphore HBV Quantification Kit

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018942039
Basic UDI-DI: 868001894PCRHPTHBVQT100D9
Reference: ABHBQ1
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Italy
Safety summary (SSCP/SSP): SSP-HBQ-Rev5 · Rev. Rev 4.0
Authorised representative: -
Last updated: 16.07.2026 12:33

Manufacturer products Open in EUDAMED View details

Atellica IM Quantitative HBsAg (QHBs)

IVDR_67_LLB_DUB-C_C_KIT_QHBs

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414246963
Basic UDI-DI: 0405686901502V7
Reference: 11200643
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ab

IVD Annex II List AIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24296UA
Basic UDI-DI: B-A24296UA
Reference: A24296
EMDN: W0105020204
EMDN description: HEPATITIS B SURFACE ANTIBODY IGG
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ag Confirmatory

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24295U8
Basic UDI-DI: B-A24295U8
Reference: A24295
EMDN: W0105020202
EMDN description: HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ag

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24291TY
Basic UDI-DI: B-A24291TY
Reference: A24291
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc Ab

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34240FZ
Basic UDI-DI: B-34240FZ
Reference: 34240
EMDN: W0105020202
EMDN description: HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion

Fluorion HBV QNP 2.0 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: 08698898740010
Basic UDI-DI: B-08698898740010
Reference: M0010202
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

Manufacturer products View details

LyoSens HBV Detection qPCR Kit

LYO78

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034897
Basic UDI-DI: B-08684595034897
Reference: LYO78
EMDN: W0105020299
EMDN description: HBV REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

RapidFor™ HBsAb Rapid Test Kit (FIA)

VMPO88

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030233
Basic UDI-DI: B-08684595030233
Reference: VMPO88
EMDN: W0105020217
EMDN description: HEPATITIS B SURFACE ANTIGEN - QUANTITATIVE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

Manufacturer products View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215053
Basic UDI-DI: B-08684387215053
Reference: IP201922-250
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215046
Basic UDI-DI: B-08684387215046
Reference: IP201922-100
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HBV qPCR Kit (Qualitative)

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215039
Basic UDI-DI: B-08684387215039
Reference: IP201922-50
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HBV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215022
Basic UDI-DI: B-08684387215022
Reference: IP201922-25
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Hepatitis B Virus (HBV) PCR Kit

GeneProof Hepatitis B Virus (HBV) PCR Kit

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304331
Basic UDI-DI: B-08595696304331
Reference: A58426
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details