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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: 06972412616879
Basic UDI-DI: 697241261IFL-A502JL
Reference: IFL-A502-07
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - 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: 06972412618088
Basic UDI-DI: 697241261IFL-502BQ
Reference: IFL-502-07
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - 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

Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICGC-62598
Basic UDI-DI: B-ICGC-62598
Reference: ICGC-625
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A+B Test (Swab/Nasal Aspirate)

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-SW02-FLAB(PRO)CM
Basic UDI-DI: B-SW02-FLAB(PRO)CM
Reference: SW02-FLAB(PRO)
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 23:41

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Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(AH5)-502aOGKU
Basic UDI-DI: B-GCFLU(AH5)-502aOGKU
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

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Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(AH5)-502aHGK7
Basic UDI-DI: B-GCFLU(AH5)-502aHGK7
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

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Flu A Ag Rapid Test Cassette (Swab)

GCFLU(A)-U502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A)-U502aOG5L
Basic UDI-DI: B-GCFLU(A)-U502aOG5L
Reference: GCFLU(A)-U502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A Ag Rapid Test Cassette (Swab)

GCFLU(A)-U502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A)-U502aHG4X
Basic UDI-DI: B-GCFLU(A)-U502aHG4X
Reference: GCFLU(A)-U502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-HIFL-522E6

Influenza A+B Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-HIFL-522E6
Basic UDI-DI: B-HIFL-522E6
Reference: HIFL-522
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H2OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H2OGEEW
Basic UDI-DI: B-GCCOV-502a-H2OGEEW
Reference: GCCOV-502a-H2OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5195

INDICAID™ HPV Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5195
Basic UDI-DI: B-A5195
Reference: INDICAID™ HPV Rapid Antigen Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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-A067DF

INDICAID™ Chikungunya Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A067DF
Basic UDI-DI: B-A067DF
Reference: INDICAID™ Chikungunya Rapid Antibody Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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-A066DD

INDICAID™ Chikungunya Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A066DD
Basic UDI-DI: B-A066DD
Reference: INDICAID™ Chikungunya Rapid Antigen Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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-697994388Ir0593VFD

HSV Herpes Simplex Virus Ab Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0593VFD
Basic UDI-DI: B-697994388Ir0593VFD
Reference: Ir059
EMDN: W0105099001
EMDN description: CMV - 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

D-697994388Ir0493SEY

COVID-19 (2019n-Cov) Antigen Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0493SEY
Basic UDI-DI: B-697994388Ir0493SEY
Reference: Ir049
EMDN: W0105099001
EMDN description: CMV - 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

D-697994388Ir0453JDS

RSV Respiratory Syncytial Virus Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0453JDS
Basic UDI-DI: B-697994388Ir0453JDS
Reference: Ir045
EMDN: W0105099002
EMDN description: RSV - 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

D-697994388Ir0433ED6

Influenza A+B Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0433ED6
Basic UDI-DI: B-697994388Ir0433ED6
Reference: Ir043
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - 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

D-697994388Ir04038BX

Norovirus GI/GII Antigen Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir04038BX
Basic UDI-DI: B-697994388Ir04038BX
Reference: Ir040
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - 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

D-697994388Ir0353FDB

Adenovirus/Rotavirus Ag Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0353FDB
Basic UDI-DI: B-697994388Ir0353FDB
Reference: Ir035
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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

D-697994388Ir0343DD2

Rotavirus Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0343DD2
Basic UDI-DI: B-697994388Ir0343DD2
Reference: Ir034
EMDN: W0105099001
EMDN description: CMV - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details