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907 device results listed.

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Strep A Antigen Rapid Test Kit (Colloidal gold method)

CR023

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473307079
Basic UDI-DI: B-06974473307079
Reference: CR023
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus Test Kit

A02167002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861682668
Basic UDI-DI: B-06973861682668
Reference: A02167002
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Diagnostic Kit for Bacterial Vaginosis (PH-VALUE)

50 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850389
Basic UDI-DI: B-06973181850389
Reference: 500080
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus Antigen Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771135
Basic UDI-DI: B-06952062771135
Reference: GAS1OP-50
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus Antigen Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771128
Basic UDI-DI: B-06952062771128
Reference: GAS1OP-25
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus Antigen Test Kit

Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771111
Basic UDI-DI: B-06952062771111
Reference: GAS2OP-50
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de antígeno de H. Pylori en casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126120
Basic UDI-DI: B-06936983126120
Reference: IHP-602
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

TROD'ANGINE+

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742691
Basic UDI-DI: B-03770011742691
Reference: TR-ANG-009
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

TetaQuick

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742301
Basic UDI-DI: B-03770011742301
Reference: TR-TET-001
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

TROD'ANGINE

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742172
Basic UDI-DI: B-03770011742172
Reference: TR-ANG-008
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

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BIOSYNEX S.pneumoniae

BIOSYNEX S. pneumoniae

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03700531700666
Basic UDI-DI: B-03700531700666
Reference: 1030002
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 19:26

Manufacturer products View details

BIOSYNEX Strep A

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700277
Basic UDI-DI: B-03700531700277
Reference: 1030005
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

CHLAMYTOP

Chlamytop

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03700531700260
Basic UDI-DI: B-03700531700260
Reference: 1030003
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 19:24

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PYLORITOP AG

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700208
Basic UDI-DI: B-03700531700208
Reference: 1030011
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

SYPHILITOP

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700178
Basic UDI-DI: B-03700531700178
Reference: 1030014
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX Legionella pneumophila BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592244
Basic UDI-DI: B-03532678592244
Reference: SW30002
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

PYLORITOP Ab BSS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678590264
Basic UDI-DI: B-03532678590264
Reference: SW30001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX S.pneumoniae BSX

BIOSYNEX S. pneumoniae BSX

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670101567
Basic UDI-DI: B-03532670101567
Reference: 1030002_BSX
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

BIOSYNEX Strep A BSX

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532670100874
Basic UDI-DI: B-03532670100874
Reference: 1030005_BSX
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:37

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX Legionella pneumophila BSX

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532670100867
Basic UDI-DI: B-03532670100867
Reference: SW30002_BSX
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:37

Manufacturer products Authorised representative products Authorised representative actors View details