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Clostridium difficile Toxin A + Toxin B 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-ICDT-R625B4N
Basic UDI-DI: B-ICDT-R625B4N
Reference: ICDT-R625B
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 22.07.2026 03:29

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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

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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

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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

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Entamoeba+Giardia+Crypto 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-IEGC-635AD
Basic UDI-DI: B-IEGC-635AD
Reference: IEGC-635
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficileToxin A+Toxin B 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-ICDT-625BZ8
Basic UDI-DI: B-ICDT-625BZ8
Reference: ICDT-625B
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Toxin A/ toxin B Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-CDT-625PB
Basic UDI-DI: B-FI-CDT-625PB
Reference: FI-CDT-625
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

HP Ag H.pylori Antigen Rapid Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: 06977775224211
Basic UDI-DI: 693869768022RS
Reference: 8022
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

06977775222316

Influenza A+B Antigen Combo Rapid Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: 06977775222316
Basic UDI-DI: 693869768062S6
Reference: 8062C01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 23:06

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IFL-A502

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412616787
Basic UDI-DI: 697241261IFL-A502JL
Reference: IFL-A502-25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

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IRS-502

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412615711
Basic UDI-DI: 697241261IRS-502JZ
Reference: IRS-502-07
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IFL-502

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412614301
Basic UDI-DI: 697241261IFL-502BQ
Reference: IFL-502-25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

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