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02.08.2026 18:51

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823 device results listed.

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LYSUN

STP-S21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712009108W
Basic UDI-DI: B-69717712009108W
Reference: STP-S21（25PCS）
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

HP-F21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712008979X
Basic UDI-DI: B-69717712008979X
Reference: HP-F21（25PCS）
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Rapid Test Cassette (Fecal Specimen)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723804
Basic UDI-DI: B-62230182723804
Reference: D-794 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723736
Basic UDI-DI: B-62230182723736
Reference: D-793 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Test

1184 001

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041023496
Basic UDI-DI: B-62230041023496
Reference: 1184 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Test

1180 001

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041023328
Basic UDI-DI: B-62230041023328
Reference: 1180 001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Gesunder Magen

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600903NQ
Basic UDI-DI: B-600903NQ
Reference: 600903
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-600901NL

Schnelltest Gesunder Magen

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600901NL
Basic UDI-DI: B-600901NL
Reference: 600901
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-600900NJ

Gesunder Magen

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600900NJ
Basic UDI-DI: B-600900NJ
Reference: 600900
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 60743840312859
Basic UDI-DI: B-60743840312859
Reference: 3026901
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 03:10

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252057
Basic UDI-DI: B-06976232252057
Reference: CA03-62-422P25
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252064
Basic UDI-DI: B-06976232252064
Reference: CA03-65-422
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252033
Basic UDI-DI: B-06976232252033
Reference: CA02-11-322P25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252019
Basic UDI-DI: B-06976232252019
Reference: CA03-19-422P25
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test (Swab)

ISB-1013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750563
Basic UDI-DI: B-06974785750563
Reference: ISB-1013
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

06973861684297

A10013001D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861684297
Basic UDI-DI: B-06973861684297
Reference: A10013001D
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST H. pylori Antigen Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173434279
Basic UDI-DI: B-04260173434279
Reference: IHP-602H
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST H. pylori Antigen Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173434132
Basic UDI-DI: B-04260173434132
Reference: IHP-602H
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

Mivolis H. pylori Antigen Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04066447834260
Basic UDI-DI: B-04066447834260
Reference: IHP-602H
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest Campylobacter

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200482
Basic UDI-DI: 84354402IDXGASTROB_CA5W
Reference: CA820001V
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details