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447 device results listed.

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LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412619412
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-20
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412614561
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-25
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618972
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-40
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303045201-01;303045201-05;303045201-20;303045201-25;303045201-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611539
Basic UDI-DI: 0697241261IRS-RA5229P
Reference: 303045201-20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303034801

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611485
Basic UDI-DI: 0697241261IRS-562BM
Reference: 303034801-20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412617159
Basic UDI-DI: 0697241261IRS-RA5229P
Reference: 303045201-05
EMDN: W0105090699
EMDN description: URINE SEDIMENTTEST KIT (MANUAL)
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618309
Basic UDI-DI: 0697241261IRS-RA5229P
Reference: 303045201-40
EMDN: W0105090699
EMDN description: URINE SEDIMENTTEST KIT (MANUAL)
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611546
Basic UDI-DI: 0697241261IRS-RA5229P
Reference: 303045201-25
EMDN: W0105090699
EMDN description: URINE SEDIMENTTEST KIT (MANUAL)
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618347
Basic UDI-DI: 0697241261IRS-562BM
Reference: 303034801-01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412614790
Basic UDI-DI: 0697241261IRS-562BM
Reference: 303034801-05
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 07:29

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: 06976232252194
Basic UDI-DI: B-06976232252194
Reference: CA03-88-422P20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test

COVID-19/ Influenza A+B/RSV 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-G45bZV
Basic UDI-DI: B-RV-G45bZV
Reference: RV-G45b
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTC-595(SSW)F9
Basic UDI-DI: B-IRTC-595(SSW)F9
Reference: IRTC-595(SSW)
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5399

INDICAID™ Respiratory 12-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5399
Basic UDI-DI: B-A5399
Reference: INDICAID™ Respiratory 12-in-1 Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5297

INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5297
Basic UDI-DI: B-A5297
Reference: INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A042CX

INDICAID™ HPV Virus Staining Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A042CX
Basic UDI-DI: B-A042CX
Reference: INDICAID™ HPV Virus Staining Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-A040CT

INDICAID™ Respiratory 6-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A040CT
Basic UDI-DI: B-A040CT
Reference: INDICAID™ Respiratory 6-in-1 Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-A039DA

INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A039DA
Basic UDI-DI: B-A039DA
Reference: INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-A041CV

INDICAID™ Respiratory 8-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A041CV
Basic UDI-DI: B-A041CV
Reference: INDICAID™ Respiratory 8-in-1 Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0463LE3

Influ A+B/ADV/RSV Ag 4-in-1 Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0463LE3
Basic UDI-DI: B-697994388Ir0463LE3
Reference: Ir046
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details