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459 device results listed.

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Norovirus/Rotavirus/Adenovirus Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-INRA-ACO6379K
Basic UDI-DI: B-INRA-ACO6379K
Reference: INRA-ACO637
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IRAC-ACO62723
Basic UDI-DI: B-IRAC-ACO62723
Reference: IRAC-ACO627
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: France
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IMVD-ACO647DE
Basic UDI-DI: B-IMVD-ACO647DE
Reference: IMVD-ACO647
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: France
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή

COVID-19 & Influenza A+B Antigen Combo Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461144
Basic UDI-DI: B-06974246461144
Reference: FCO-6032H
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Share info GmbH
Last updated: 28.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Candida/Trichomonas Vaginalis/Gardnerella Vaginalis Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A078DL
Basic UDI-DI: B-A078DL
Reference: P0191
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

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: 06972412614707
Basic UDI-DI: 0697241261IRS-562BM
Reference: 303034801-40
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 22.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303034002

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612277
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-05
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 22.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303041901

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611454
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901-20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 22.07.2026 00:47

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: 06972412617739
Basic UDI-DI: 0697241261IRS-562BM
Reference: 303034801-25
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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 BNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412614721
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901-01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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 BNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613823
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901-05
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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 BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412619641
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901-40
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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: 06972412613632
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-01
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: 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