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06955792700888

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792700888
Basic UDI-DI: 69557927S3102E000001M5
Reference: S3102E-48
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® Human coronavirus OC43 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R04EK
Basic UDI-DI: B-1R04EK
Reference: 1R04
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 21.09.2026 23:23

Manufacturer products View details

mariPOC® SARS-CoV-2 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R13EL
Basic UDI-DI: B-1R13EL
Reference: 1R13
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 21.09.2026 23:23

Manufacturer products View details

RapidFor™

VMD78SC

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998279840
Basic UDI-DI: 868499827VMD78SCG5
Reference: VMD78SC
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:48

Manufacturer products View details

RapidFor™

VMD95

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548255006
Basic UDI-DI: 868354825VMD95SC46
Reference: VMD95SC
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:48

Manufacturer products View details

RapidFor™

HPIV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941643
Basic UDI-DI: 868459503VMD151SC9Q
Reference: VMD151SC01
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:47

Manufacturer products View details

RapidFor™

VMD151SC

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039915
Basic UDI-DI: 868459503VMD151SC9Q
Reference: VMD151SC
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:47

Manufacturer products View details

RapidFor™

VMD83

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548253590
Basic UDI-DI: 868354825VMD83SC3M
Reference: VMD83SC
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:42

Manufacturer products View details

RapidFor™

ADV Resp. Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277846
Basic UDI-DI: 868354825VMD83SC3M
Reference: VMD83TD
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:42

Manufacturer products View details

RapidFor™

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277853
Basic UDI-DI: 868354825VMD83SC3M
Reference: VMD83SD
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:42

Manufacturer products View details

RapidFor™

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277860
Basic UDI-DI: 868354825VMD83SC3M
Reference: VMD83BC
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:42

Manufacturer products View details

RapidFor™

Chikungunya IgG/IgM Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277723
Basic UDI-DI: 868334794VMD52BD2H
Reference: VMD52BDLA
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 21:48

Manufacturer products View details

EBV ViraChip IgG Weak Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIREBCGWK1
Basic UDI-DI: ++EVIREBVIgGControlK4
Reference: V-EBCGWK
EMDN: W010504040102
EMDN description: EBV IGG - TOTAL
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:46

Manufacturer products View details

EBV ViraChip IgG,A,M Negative Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIREBCPNK1
Basic UDI-DI: ++EVIREBVIgGControlK4
Reference: V-EBCPNK
EMDN: W010504040102
EMDN description: EBV IGG - TOTAL
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:46

Manufacturer products View details

EBV ViraChip IgM Weak Positive Control

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIREBCMWK1
Basic UDI-DI: ++EVIREBVIgMControlNN
Reference: V-EBCMWK
EMDN: W010504040103
EMDN description: EBV IGM - TOTAL
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:46

Manufacturer products View details

RSV/ADV Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148129
Basic UDI-DI: 697334914RJ07MC
Reference: RJ07-5
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/ADV Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148136
Basic UDI-DI: 697334914RJ07MC
Reference: RJ07-20
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/ADV Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148143
Basic UDI-DI: 697334914RJ07MC
Reference: RJ07-25
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/ADV Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148150
Basic UDI-DI: 697334914RJ07MC
Reference: RJ07-50
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

AccuProbe RSV PCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349141151
Basic UDI-DI: 697334914HS37LU
Reference: HS37-20
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details