Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

19.09.2026 23:51

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3283

Filters

Show filters

Active filter:EMDN:W01050205

80 device results listed.

Page 1 / 4

CSV XML

LyoSens™

HEV qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258908
Basic UDI-DI: 868511580PCR43JC
Reference: LYO43WS24
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 07.08.2026 02:54

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805416
Basic UDI-DI: 868511580PCR43JC
Reference: LYO43WS48
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:58

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805454
Basic UDI-DI: 868511580PCR43JC
Reference: LYO43WS96
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:58

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031803
Basic UDI-DI: 868511580PCR43JC
Reference: CFP43P25
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:57

Manufacturer products View details

ChainFor™

HEV qPCR Kit

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033456
Basic UDI-DI: 868511580PCR43JC
Reference: CFP43P50
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 06.08.2026 22:57

Manufacturer products View details

ChainFor™

CFP70

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257703
Basic UDI-DI: 868511580PCR43JC
Reference: CFP43P100
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.08.2026 22:57

Manufacturer products View details

MP Diagnostics HEV lgM ELISA 3.0

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000535
Basic UDI-DI: B-08887581000535
Reference: 23160-096
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735286

Hepatitis E Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735286
Basic UDI-DI: B-06955792735286
Reference: S3183E-24
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020054

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020054
Basic UDI-DI: B-06936791020054
Reference: WG0301-20
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791010062

96 tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791010062
Basic UDI-DI: B-06936791010062
Reference: WG0101-96
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

05061059980540

ZENA MAX Hepatitis E Virus Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980540
Basic UDI-DI: B-05061059980540
Reference: KD91241-100
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors 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 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

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

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