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TREN

Last updated

22.09.2026 11:56

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Device

3537178

Actor

47731

Certificate

3381

Active filter:EMDN:W0105040504

157 device results listed.

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EasyNAT Rapid Flu Assay

EasyNAT Rapid Flu Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN
CN-MF-000014615
UDI-DI
06973492240190
Basic UDI-DI
697349224U2020062B000FE
Reference
U20206
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 14:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Panther Fusion Paraflu Assay

Panther Fusion Paraflu Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045509306
Basic UDI-DI
54200455DIAGPFPARAFLURZ
Reference
PRD-04329
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Belgium
Authorised representative
Hologic BV
Last updated
02.07.2026 04:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Panther Fusion Flu A/B/RSV Assay

Panther Fusion Flu A/B/RSV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045509283
Basic UDI-DI
54200455DIAGPFFLUABRSVWG
Reference
PRD-04328
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Belgium
Authorised representative
Hologic BV
Last updated
02.07.2026 04:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
04049095210143

RIDA®UNITY Parainfluenza

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095210143
Basic UDI-DI
4049095UN58050000UJ
Reference
UN5805
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
01.07.2026 18:52
Manufacturer productsView details
04049095210044

RIDA®UNITY Flu

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095210044
Basic UDI-DI
4049095UN05050000PY
Reference
UN0505
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
01.07.2026 18:52
Manufacturer productsView details
06970895476096

Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN
CN-MF-000001539
UDI-DI
06970895476096
Basic UDI-DI
B-06970895476096
Reference
R083T010B0C1
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Germany
Authorised representative
SUNGO Europe B.V.
Last updated
30.06.2026 09:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970895476089

Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN
CN-MF-000001539
UDI-DI
06970895476089
Basic UDI-DI
B-06970895476089
Reference
R083T050B0C1
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Germany
Authorised representative
SUNGO Europe B.V.
Last updated
30.06.2026 09:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Panther Fusion Flu A/B/RSV Assay Controls Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hologic
Manufacturer SRN
US-MF-000001646
UDI-DI
15420045509313
Basic UDI-DI
54200455DIAGPFFLUABRSVWG
Reference
PRD-04336
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Hologic BV
Last updated
29.06.2026 13:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)

Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792731080
Basic UDI-DI
B-06955792731080
Reference
S3044E
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
France
Authorised representative
Obelis s.a.
Last updated
28.06.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)

-

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843227924
Basic UDI-DI
697384322BSJ04JG
Reference
BSJ04M1
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
MedNet EC-REP GmbH
Last updated
16.06.2026 13:13
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)

-

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843227931
Basic UDI-DI
697384322BSJ04JG
Reference
BSJ04S1
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
MedNet EC-REP GmbH
Last updated
16.06.2026 13:13
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR)

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN
CN-MF-000012807
UDI-DI
06974849369601
Basic UDI-DI
697484936W01050405V2
Reference
HWTS-RT176B
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
16.06.2026 12:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR)

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN
CN-MF-000012807
UDI-DI
06974849369618
Basic UDI-DI
697484936W01050405V2
Reference
HWTS-RT176C
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
16.06.2026 12:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR)

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN
CN-MF-000012807
UDI-DI
06974849369625
Basic UDI-DI
697484936W01050405V2
Reference
HWTS-RT176D
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
16.06.2026 12:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR)

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN
CN-MF-000012807
UDI-DI
06974849369632
Basic UDI-DI
697484936W01050405V2
Reference
HWTS-RT176E
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
16.06.2026 12:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details