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Strep A Rapid Test Device

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804804558
Basic UDI-DI: 69528048A463101ZT
Reference: A4631011
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804837174
Basic UDI-DI: 69528048A463101ZT
Reference: A4631021
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0371

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: D-1001-0371C2
Basic UDI-DI: B-1001-0371C2
Reference: 1001-0371
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 06:49

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OraQuick HCV Rapid Antibody Test

1001-0370

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: D-1001-0370BY
Basic UDI-DI: B-1001-0370BY
Reference: 1001-0370
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 06:49

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Vibrio cholerae O139 (VC O139) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCB-602GY
Basic UDI-DI: B-IVCB-602GY
Reference: IVCB-602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

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Vibrio cholerae O1/O139 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-IVCAB-6258U
Basic UDI-DI: B-IVCAB-6258U
Reference: IVCAB-625
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

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Vibrio cholerae O1 (VC O1) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCA-602GM
Basic UDI-DI: B-IVCA-602GM
Reference: IVCA-602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDEN-402C2
Basic UDI-DI: B-IDEN-402C2
Reference: IDEN-402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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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

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

LYHER

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