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305 device results listed.

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Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FCO6032PSYNG
Basic UDI-DI: B-697424646FCO6032PSYNG
Reference: FCO-6032
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: NIC GmbH
Last updated: 17.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FCO000PKX7H
Basic UDI-DI: B-697424646FCO000PKX7H
Reference: FCO-6032a/FCO-6032b
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960ACAB04DJXYT

ACAB04D-BOG48E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ACAB04DJXYT
Basic UDI-DI: B-69509960ACAB04DJXYT
Reference: ACAB04D-BOG48E
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&Flu A/B&RSV&Adenovirus&MP&HMPV Antigen Combo Rapid Test Cassette(Colloidal Gold )

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698404714
Basic UDI-DI: B-06977698404714
Reference: GKPD098
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:37

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&Flu A/B&RSV&Adenovirus&MPAntigen Combo Rapid TestCassette(Colloidal Gold)

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698404653
Basic UDI-DI: B-06977698404653
Reference: GKPD097
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:37

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&Flu A/B&RSV&Adenovirus Antigen Combo Rapid Test Cassette(Colloidal Gold )

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698404608
Basic UDI-DI: B-06977698404608
Reference: GKPD096
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:37

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252170
Basic UDI-DI: B-06976232252170
Reference: CA03-112-322P15
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252118
Basic UDI-DI: B-06976232252118
Reference: CA03-48-422P25
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252095
Basic UDI-DI: B-06976232252095
Reference: CA03-56-422P15
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

ACMEX

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251999
Basic UDI-DI: B-06976232251999
Reference: CA03-53-422P25
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251982
Basic UDI-DI: B-06976232251982
Reference: CA03-57-422P20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B/Adeno/RSV/COVID-19/MP Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750549
Basic UDI-DI: B-06974785750549
Reference: IABC-1063
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

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

SARS-CoV-2/Influenza A+B Ag Combo Rapid Test

VLD01-03-13

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VLD01-03-13D6
Basic UDI-DI: B-VLD01-03-13D6
Reference: VLD01-03-13-011
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:24

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