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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

Manufacturer products View details

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

Group A streptococcus Rapid test Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-012124L3
Basic UDI-DI: B-012124L3
Reference: 012124-20-111
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Finland
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details

Artron ONE STEP Tuberculosis Antibody (TB Ab) Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561383
Basic UDI-DI: B-00628347561383
Reference: A03-07-222
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Helicobacter pylori (HP) Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561222
Basic UDI-DI: B-00628347561222
Reference: A02-11-422
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Helicobacter Pylori (HP) Antibody Test

cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561178
Basic UDI-DI: B-00628347561178
Reference: A02-11-222
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561123
Basic UDI-DI: B-00628347561123
Reference: A02-09-322
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561116
Basic UDI-DI: B-00628347561116
Reference: A02-09-222
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron One Step Treponema Pallidum (TP) Antibody Test

Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561109
Basic UDI-DI: B-00628347561109
Reference: A02-09-213
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel® Ulcer (H. pylori) Screening Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059100518
Basic UDI-DI: B-00083059100518
Reference: 1005-1
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

LoopReagent

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Loop Diagnostics S.L.
Manufacturer SRN: ES-MF-000047379
UDI-DI: 08437024928010
Basic UDI-DI: 8437024928SL001R8B
Reference: SL001R
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:14

Manufacturer products View details

VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag

VRC005

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290883
Basic UDI-DI: 843661029VRC00501Q6
Reference: VRC005
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag

VRC004

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290876
Basic UDI-DI: 843661029VRC00401PZ
Reference: VRC004
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

VIRAPID® STREPTOCOCCUS GROUP A Ag

VRC003

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290869
Basic UDI-DI: 843661029VRC00301PU
Reference: VRC003
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details