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RapidFor™

VSCD02ST01

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250001
Basic UDI-DI: B-08683548250001
Reference: VSCD02ST
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 18:46

Manufacturer products View details

Chikungunya lgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICHIM-402(AT)TM
Basic UDI-DI: B-ICHIM-402(AT)TM
Reference: ICHIM-402
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-RT-575(AT)P5
Basic UDI-DI: B-FI-RT-575(AT)P5
Reference: FI-RT-575
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens™

Parvovirus B19 qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259141
Basic UDI-DI: 868511580PCR64JL
Reference: LYO64WS24
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: -
Last updated: 12.08.2026 23:33

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805829
Basic UDI-DI: 868511580PCR64JL
Reference: LYO64WS48
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:47

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805867
Basic UDI-DI: 868511580PCR64JL
Reference: LYO64WS96
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:47

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032039
Basic UDI-DI: 868511580PCR64JL
Reference: CFP64P25
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:47

Manufacturer products View details

06975068491074

25Tests/kit

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491074
Basic UDI-DI: B-06975068491074
Reference: CP109.B1
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.08.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140174
Basic UDI-DI: B-06958982140174
Reference: AB30-20
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)

Model A：25test/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 16972235840038
Basic UDI-DI: B-16972235840038
Reference: LCV07
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

ZiKA IgG/IgM Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140389
Basic UDI-DI: B-06958982140389
Reference: AB220-20
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Croatia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

CHIK IgG/IgM Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140372
Basic UDI-DI: B-06958982140372
Reference: AB210-20
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Croatia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140310
Basic UDI-DI: B-06958982140310
Reference: AB31-20
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgM/IgG Ab Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140112
Basic UDI-DI: B-06958982140112
Reference: AB290-20
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atlas

8.16.37.0.0020

IVD generalIVDDOn the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04262408511793
Basic UDI-DI: B-04262408511793
Reference: 8.16.37.0.0020
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:43

Manufacturer products View details

Rapid Zika Virus IgG/IgM Combo Test Card

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316073
Basic UDI-DI: B-04260163316073
Reference: 07ZIKA025AB
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:42

Manufacturer products View details

Rapid Zika Virus IgG/IgM Combo Test Card

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316066
Basic UDI-DI: B-04260163316066
Reference: 07ZIKA001AB
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:42

Manufacturer products View details

04099466102034

Serazym® Rotavirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466102034
Basic UDI-DI: B-04099466102034
Reference: E-020
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

Manufacturer products View details

04099466101730

Serazym® Adenovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466101730
Basic UDI-DI: B-04099466101730
Reference: E-017
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

Manufacturer products View details

Anti-Oropouche Virus ELISA (IgM)

EI 2771 M

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016164036
Basic UDI-DI: 4049016EI2771M57
Reference: EI 2771-9601 M
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:17

Manufacturer products View details