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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

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: 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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Adenovirus IgG

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147182878
Basic UDI-DI: B-86060147182878
Reference: N101V24IGG
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

Influenza A+B Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-FLU-502TY
Basic UDI-DI: B-FI-FLU-502TY
Reference: FI-FLU-502
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Biotrin Parvovirus B19 IgM Plus

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: 08056771104043
Basic UDI-DI: 80567713115604G
Reference: 311560
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

H1N1 Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFA-502LQ
Basic UDI-DI: B-IFA-502LQ
Reference: IFA-502
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

H1N1 Antigen Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFA-501LN
Basic UDI-DI: B-IFA-501LN
Reference: IFA-501
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IAD-502KQ
Basic UDI-DI: B-IAD-502KQ
Reference: IAD-502
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Ebola Virus Nucleic Acid Detection Kit

Ebola Virus Nucleic Acid Detection Kit (Lyophilized Fluorescent PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911213
Basic UDI-DI: B-06974238911213
Reference: PEB001
EMDN: W0105040627
EMDN description: EBOLA (FILOVIRUS)
First on market country: Italy
Authorised representative: Immuno International BV
Last updated: 26.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Biotrin Parvovirus B19 IgG Plus

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: 08056771104005
Basic UDI-DI: 80567713115404A
Reference: 311540
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® Biotrin Parvovirus B19 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101165
Basic UDI-DI: B-08056771101165
Reference: 317010
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

Zika NS1 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IZIG-402NX
Basic UDI-DI: B-IZIG-402NX
Reference: IZIG-402
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM and NS1 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-IZIC-425MX
Basic UDI-DI: B-IZIC-425MX
Reference: IZIC-425
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details