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227 device results listed.

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HAV IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHA-402MD
Basic UDI-DI: B-IHA-402MD
Reference: IHA-402
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® MUREX Anti-HEV IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103916
Basic UDI-DI: 805677131128047
Reference: 311280
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

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LIAISON® MUREX Anti-HEV IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103879
Basic UDI-DI: 805677131127044
Reference: 311270
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

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LIAISON® Anti-HAV

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100151
Basic UDI-DI: 80567713101703Q
Reference: 310170
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

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ADVIA Centaur aHAVT assay

IVDR_67_TTN_DUB-C_B_KIT_aHAVT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414481876
Basic UDI-DI: 0405686900748W2
Reference: 10322676
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IGG IGM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312096
Basic UDI-DI: B-69743840312096
Reference: 3023101
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

HAV-W21-GM（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-6971771200989A5
Basic UDI-DI: B-6971771200989A5
Reference: HAV-W21-GM
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic kit for anti-HAV IgM( Colloidal Gold)

HAV-IgM strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990612QC
Basic UDI-DI: B-693757990612QC
Reference: HAV-IgM 501201 HAV-IgM 251202
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® HCV VL Fingerstick

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940006433
Basic UDI-DI: B-07332940006433
Reference: GXHCV-FS-CE-10
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

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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

Xpert®

Xpert® HCV Viral Load

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001544
Basic UDI-DI: B-07332940001544
Reference: GXHCV-VL-CE-10
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

HAV Rapid Test Cassette (Serum/Plasma)

IHA-6013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750594
Basic UDI-DI: B-06974785750594
Reference: IHA-6013
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIHEVM078009

NovaLisa® Hepatitis E Virus (HEV) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHEVM078009
Basic UDI-DI: B-+ENTIHEVM078009
Reference: HEVM0780
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHEVG078003

NovaLisa® Hepatitis E Virus (HEV) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHEVG078003
Basic UDI-DI: B-+ENTIHEVG078003
Reference: HEVG0780
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

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

08905459006912

RPDHCV-01 RPDHCV-03

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

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006912
Basic UDI-DI: 8905459MHCVRT9A
Reference: RPDHCV-03
EMDN: W0105020308
EMDN description: HEPATITIS C VIRUS (HCV) ANTIGEN/ANTIBODY COMBO TEST
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/019 · 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

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

08033629924589

GEN-C 3.0

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629924589
Basic UDI-DI: 803362992GENHCVD6
Reference: AC004/24
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details