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228 device results listed.

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EIAgen HCV Ab (v.4) Kit

++M52107106LG

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52107106LG
Basic UDI-DI: B-++M52107106LG
Reference: 071067 / 071064 / 071068
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Poland
Authorised representative: -
Last updated: 01.08.2026 01:56

Manufacturer products View details

HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST

VCM093

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040327838
Basic UDI-DI: 843604032VCM09301DK
Reference: VCM093
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

HEPATITIS E VIRCLIA® IgM MONOTEST

VCM067

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326954
Basic UDI-DI: 843604032VCM06701DJ
Reference: VCM067
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

HEPATITIS E VIRCLIA® IgG MONOTEST

VCM066

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326947
Basic UDI-DI: 843604032VCM06601DD
Reference: VCM066
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

Hepatitis E Virus IgG Antibody (CLIA)

105-038864-00, 105-038865-00, 105-045978-00, 105-045977-00, 105-045975-00, 105-045976-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049313
Basic UDI-DI: 69449040AB74000425L
Reference: 105-038865-00
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus IgM Antibody (CLIA)

105-038860-00, 105-038861-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049283
Basic UDI-DI: 69449040AB74000395X
Reference: 105-038860-00
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to Hepatitis A Virus (CLIA)

105-038862-00, 105-038863-00, 105-045982-00, 105-045981-00, 105-045980-00, 105-045979-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049207
Basic UDI-DI: 69449040AB74000405G
Reference: 105-038862-00
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody (CLIA)

105-038866-00, 105-038867-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049122
Basic UDI-DI: 69449040AB74000415J
Reference: 105-038866-00
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® Anti-HEV IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026467326
Basic UDI-DI: 357302BUDI000856UD
Reference: 418116
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

VIDAS® Anti-HEV IgM

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026467319
Basic UDI-DI: 357302BUDI000855UB
Reference: 418115
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products 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

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products 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

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