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907 device results listed.

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AMA RUT Pro (block of 24)

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: «Association of Medicine and Analytics» Company Limited
Manufacturer SRN: RU-MF-000036645
UDI-DI: D-4680008050206VGET
Basic UDI-DI: B-4680008050206VGET
Reference: 0206
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

AMA RUT Expert

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: «Association of Medicine and Analytics» Company Limited
Manufacturer SRN: RU-MF-000036645
UDI-DI: D-4680008050205VEEJ
Basic UDI-DI: B-4680008050205VEEJ
Reference: 0205
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

HELIC ABT Reader indicator tube kit (30 pcs)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: «Association of Medicine and Analytics» Company Limited
Manufacturer SRN: RU-MF-000036645
UDI-DI: D-4680008050109VHEZ
Basic UDI-DI: B-4680008050109VHEZ
Reference: 0109
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

HELIC ABT Reader indicator tube kit (1 pcs)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: «Association of Medicine and Analytics» Company Limited
Manufacturer SRN: RU-MF-000036645
UDI-DI: D-4680008050107VDEF
Basic UDI-DI: B-4680008050107VDEF
Reference: 0107
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

HELIC ABT Reader indicator tube kit (50 pcs)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: «Association of Medicine and Analytics» Company Limited
Manufacturer SRN: RU-MF-000036645
UDI-DI: D-4680008050106VBE6
Basic UDI-DI: B-4680008050106VBE6
Reference: 0106
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL Strep A Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-222901N-2069
Basic UDI-DI: B-222901N-2069
Reference: 222901N-20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 15:28

Manufacturer products View details

NADAL Strep A Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-221901N-405U
Basic UDI-DI: B-221901N-405U
Reference: 221901N-40
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 15:28

Manufacturer products View details

Rapid Leptospira IgG/IgM Combo Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-1O23C2Y5
Basic UDI-DI: B-1O23C2Y5
Reference: 1O23C2-1-EU, 1O23C2-25-EU
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 11.07.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

B. pertussis Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698604161
Basic UDI-DI: B-16972698604161
Reference: P211106
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603720
Basic UDI-DI: B-16972698603720
Reference: P231119
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Shigella Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603706
Basic UDI-DI: B-16972698603706
Reference: P221110
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae O1/O139 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603690
Basic UDI-DI: B-16972698603690
Reference: P221108
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Campylobacter Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603683
Basic UDI-DI: B-16972698603683
Reference: P221107
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella Typhi IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603645
Basic UDI-DI: B-16972698603645
Reference: P231118
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603669
Basic UDI-DI: B-16972698603669
Reference: P281003
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella Typhi Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603652
Basic UDI-DI: B-16972698603652
Reference: P221106
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Antigen Rapid Test Device

P241110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600101
Basic UDI-DI: B-16972698600101
Reference: P241110
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

16952999401324

IST-502

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 16952999401324
Basic UDI-DI: B-16952999401324
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

16952999401317

IST-501

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 16952999401317
Basic UDI-DI: B-16952999401317
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Strep A Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763167
Basic UDI-DI: B-15065023763167
Reference: TV10017
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details