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Rapid V.Cholerae O139 Test Strip

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315687
Basic UDI-DI: B-04260163315687
Reference: 07VCH139S
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Rapid V. cholerae O1 Test Card

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315670
Basic UDI-DI: B-04260163315670
Reference: 07VCHO1C
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Rapid V. cholerae O1 Test Strip

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315663
Basic UDI-DI: B-04260163315663
Reference: 07VCHO1S
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

CupiKIT

Syphilis Antibody Test Kit

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

Manufacturer: Cupid Limited
Manufacturer SRN: IN-MF-000033199
UDI-DI: 08906005286086
Basic UDI-DI: 890600528cupsypPT
Reference: CUPSYP-01
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: Amstermed B.V.
Last updated: 04.08.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IVC-ACO63552
Basic UDI-DI: B-IVC-ACO63552
Reference: IVC-ACO635
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IVC-ACO6024K
Basic UDI-DI: B-IVC-ACO6024K
Reference: IVC-ACO602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Lithuania
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IMT-ACO9028N
Basic UDI-DI: B-IMT-ACO9028N
Reference: IMT-ACO902
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans and Trichomonas Vaginalis Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICT-ACO525Z5
Basic UDI-DI: B-ICT-ACO525Z5
Reference: ICT-ACO525
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Greece
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICDT-R625BacroX9
Basic UDI-DI: B-ICDT-R625BacroX9
Reference: ICDT-R625B
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Campylobacter Rapid Test Device – Feces

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-D-CAMD10Z4
Basic UDI-DI: B-D-CAMD10Z4
Reference: D-CAMD10
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Advena Limited
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-MP-502QN
Basic UDI-DI: B-ACO-MP-502QN
Reference: ACO-MP-502
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH+Toxin A/B Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CD-602GM
Basic UDI-DI: B-ACO-CD-602GM
Reference: ACO-CD-602
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag MonlabTest

MO-804001 25 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: MONLAB SL
Manufacturer SRN: ES-MF-000001438
UDI-DI: 08436539090496
Basic UDI-DI: B-08436539090496
Reference: MO-804001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 04:25

Manufacturer products View details

S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)

Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277514644
Basic UDI-DI: B-06970277514644
Reference: ISLC-125
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511162
Basic UDI-DI: B-06970277511162
Reference: ISY-302
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277510479
Basic UDI-DI: B-06970277510479
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

06941571897009

R97-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571897009
Basic UDI-DI: B-06941571897009
Reference: R97-112
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941571892028

R92-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571892028
Basic UDI-DI: B-06941571892028
Reference: R92-116
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941571892011

R92-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571892011
Basic UDI-DI: B-06941571892011
Reference: R92-112
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941571892004

R92-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571892004
Basic UDI-DI: B-06941571892004
Reference: R92-110
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:56

Manufacturer products Authorised representative products Authorised representative actors View details