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ichroma™ Dengue NS1 Ag

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042212
Basic UDI-DI: 880613300028BR
Reference: CFPC-62
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Dengue IgG/IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042137
Basic UDI-DI: 880613300027BP
Reference: CFPC-60
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Hungary
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Dengue IgG/IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042090
Basic UDI-DI: 880613300548CQ
Reference: SMFP-41
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

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AFIAS NORO

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041796
Basic UDI-DI: 880613300530C5
Reference: SMFP-26
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

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TICK-BORNE ENCEPHALITIS VIRCLIA® IgG MONOTEST

VCM047

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326862
Basic UDI-DI: 843604032VCM04701D4
Reference: VCM047
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

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ZIKA VIRCLIA® IgG MONOTEST

VCM033

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326732
Basic UDI-DI: 843604032VCM03301C9
Reference: VCM033
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

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B19 IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552516
Basic UDI-DI: 697015090000276HT
Reference: CMK1205
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

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B19 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552417
Basic UDI-DI: 697015090000275HR
Reference: CMK1105
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

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Rotavirus and Adenovirus Combo Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104432
Basic UDI-DI: 6970277510000DXH
Reference: IRAC-N625
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

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B19 IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552493
Basic UDI-DI: 697015090000276HT
Reference: CMK1203
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

B19 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552394
Basic UDI-DI: 697015090000275HR
Reference: CMK1103
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

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Novel Coronavirus (SARSCoV-2) Real Time Multiplex RT-PCR Kit

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212460
Basic UDI-DI: B-06933260212460
Reference: /
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

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ROTAVIRUS RAPID TEST CASSETTE (FECES)

RAPID TEST CASSETTE

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Tody Laboratories Int. SRL
Manufacturer SRN: RO-MF-000032726
UDI-DI: 05944760250020
Basic UDI-DI: 594476025TESTERAPIDEUY
Reference: C61RT1005
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:27

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VIDAS® Anti-CHIKUNGUNYA IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026626167
Basic UDI-DI: 357302BUDI000921TX
Reference: 423230-30
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

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VIDAS® Anti-CHIKUNGUNYA IgM

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026626150
Basic UDI-DI: 357302BUDI000920TV
Reference: 423229-30
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

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VIDAS® Anti-CHIKUNGUNYA IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026610357
Basic UDI-DI: 357302BUDI000921TX
Reference: 423230
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

Manufacturer products View details

VIDAS® Anti-CHIKUNGUNYA IgM

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026610340
Basic UDI-DI: 357302BUDI000920TV
Reference: 423229
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

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VIDAS® DENGUE NS1 Ag

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608217
Basic UDI-DI: 357302BUDI000852U5
Reference: 423077
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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Astrovirus Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IAS-R602DB
Basic UDI-DI: B-IAS-R602DB
Reference: IAS-R602
EMDN: W0105040629
EMDN description: ASTROVIRUS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus IgM

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147182946
Basic UDI-DI: B-86060147182946
Reference: N102V24IGM
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 02:29

Manufacturer products Authorised representative products Authorised representative actors View details