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276 device results listed.

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VIDAS® Anti-HAV Total

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064792
Basic UDI-DI: 357302BUDI000232SZ
Reference: 30312
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® HAV IgM

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064747
Basic UDI-DI: 357302BUDI000593U4
Reference: 30307
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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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

LIAISON® HAV IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100175
Basic UDI-DI: B-08056771100175
Reference: 310180
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

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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

HEV RNA QUANTITATION (QT)

HEVONEQT.CE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616042644
Basic UDI-DI: B-08050616042644
Reference: HEVONEQT.CE
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

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D-Z1350058

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z1350058
Basic UDI-DI: B-Z1350058
Reference: Z13500
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:52

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D-Z133705K

N/A

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z133705K
Basic UDI-DI: B-Z133705K
Reference: Z13370
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

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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

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HEV IgG/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-IHE-302NL
Basic UDI-DI: B-IHE-302NL
Reference: IHE-302
EMDN: W0105020503
EMDN description: HEV ANTIBODY (TOTAL)
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

HAV IgG/IgM Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHAGM-4255D
Basic UDI-DI: B-IHAGM-4255D
Reference: IHA-402
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
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

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details