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311 device results listed.

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06979890910680

Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910680
Basic UDI-DI: 69798909110001CD
Reference: RVC-555b-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 16.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303021901

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611515
Basic UDI-DI: 0697241261IRS-542BF
Reference: 303021901
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303034701-01;303034701-05;303034701-20;303034701-25;303034701-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611492
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

B7149000120

SAMBA III SCoV-2/Flu/RSV Test

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Diagnostics for the Real World Ltd
Manufacturer SRN: US-MF-000023951
UDI-DI: B7149000120
Basic UDI-DI: ++B7149000122R
Reference: 9000-12
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-STYS-K02a2U
Basic UDI-DI: B-STYS-K02a2U
Reference: STYS-K02a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

8-in-1 Respiratory Antigen Combo Rapid Test

RVC-585b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-RVC-585bLL
Basic UDI-DI: B-RVC-585bLL
Reference: RVC-585b
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 15.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test

RVC-555b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-RVC-555bL5
Basic UDI-DI: B-RVC-555bL5
Reference: RVC-555b
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 15.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-RVC-5105a63

RVC-5105a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-RVC-5105a63
Basic UDI-DI: B-RVC-5105a63
Reference: RVC-5105a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 15.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RV-G65a28
Basic UDI-DI: B-RV-G65a28
Reference: RV-G65a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RV-B55aYV
Basic UDI-DI: B-RV-B55aYV
Reference: RV-B55a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RAV-F22aKD
Basic UDI-DI: B-RAV-F22aKD
Reference: RAV-F22a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-IRTC-5X5(SSW)X7

Multiplex Respiratory Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTC-5X5(SSW)X7
Basic UDI-DI: B-IRTC-5X5(SSW)X7
Reference: IRTC-5X5(SSW)
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Rotavirus & Adenovirus & Norovirus Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD154XM
Basic UDI-DI: B-GKPD154XM
Reference: GKPD154
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

RSV & ADV Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD147XQ
Basic UDI-DI: B-GKPD147XQ
Reference: GKPD147
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii IgG/IgM, CMV IgG/IgM and Rubella Virus IgG Antibody Combo Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD141XC
Basic UDI-DI: B-GKPD141XC
Reference: GKPD141
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis Triplex Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD138XP
Basic UDI-DI: B-GKPD138XP
Reference: GKPD138
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Rotavirus / Adenovirus / Norovirus Antigen Triplex Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD132XB
Basic UDI-DI: B-GKPD132XB
Reference: GKPD132
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus 71 (EV71) IgM/IgG Antibody and Coxsackievirus A16 (CA16) IgM/IgG Antibody Combo Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD131X9
Basic UDI-DI: B-GKPD131X9
Reference: GKPD131
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD128XL
Basic UDI-DI: B-GKPD128XL
Reference: GKPD128
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Virus IgG/IgM Antibody and Yellow Fever Virus IgG/IgM Antibody Combo Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD122X8
Basic UDI-DI: B-GKPD122X8
Reference: GKPD122
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details